Testservice

and bring your products safely onto the Canadian market

Certification Experts is your full-service compliance partner and guides you through the complete Canadian compliance process according to CSA standards, CCOHS requirements, FCC, ICES requirements and CCPSA. With over 25 years of experience, our team of experts will help you to obtain access to the Canadian market.

Summary

A quick overview of this page

Canadian compliance

To be able to enter the Canadian market, you need to ensure that your product is safe. This can be done through measures such as using CSA standards, COOHS, FCC and ICES requirements and CCPSA, which are used to assess and certify the products in accordance with Federal Regulations and National Codes.

Challenges of compliance Canada

Obtaining Canadian compliance can be a complicated process. For this, it is important to consider which products require which certification. Herein, time and knowledge of regulations must be taken into account during the process to complete the compliance process.

Guidance from start to finish

Our team will guide you through all processes and perform testing in order for your products to be able to obtain Canadian compliance. As your full-service compliance partner, we will ease this lengthy and complicated process.
Experts

Let our dedicated team of experts handle the Canadian compliance process for your products

CE Marking: Obtain Canadian compliance

To be able to enter the Canadian market your products must be in compliance. This can be done through measures which are used to assess and certify the products in accordance with the Federal Regulations and National Codes, such as:

  • Industrial equipment and products used as work tools in a work or professional environment: are regulated by the Canadian Centre for Occupational Health and Safety (CCOHS)
  • Electrical and electronic products susceptible to (unwanted) electronic emissions or electromagnetic interference: are regulated by the Dept of Communications within Canada and must be in compliance with ICES requirements.
  • Medical Devices: class I are regulated by the Medical Device Establishment License (MDEL) and class II, III and IV are regulated by Medical Device License (MDL)
  • Consumer products: are regulated by the Canada Consumer Product Safety Act (CCPSA)
  • Toy safety: regime is in effect under the Canada Consumer Product Safety Act (CCPSA). There are several regulations under the CCPSA that address specific hazards with children’s toys, the main regulation is the Toys Regulations (SOR/2011-17)

What does it mean to be CSA approved?

CSA is an abbreviation for Canadian Standards Association. This CSA marking is considered to be the equivalent of the CE mark which is used in the European Union. CSA labels are certified by CSA International. Herein, they offer certification for electrical products, mechanical products, or ‘at risk’ ones in general. The CSA logo indicates that the product has been tested according to Canadian standards and that the product complies with requirements of this standard.\  The CSA marking is however not a legally mandatory marking, unless legislated by government or mandated by industry or trade associations. Manufacturers are under the impression that they should make use of CSA, which is a National Recognized Testing Laboratory (NRTL). CSA is a two-pronged organisation: The organisation develops standards and acts as a NRTL. An Authority Having Jurisdiction (AHJ\’s) can confirm whether a product complies to the requirements for the Canadian market and this decision is always based on reports from a NRTL. The CSA standards are considered as the legislative safety requirements; other NRTL\’s can also use these standards to evaluate products. The AHJ’s make no distinction between the different NRTLs, given that all NRTLs are accredited organisations. Certification Experts has a partner that is a Nationally Recognized Testing Laboratory and is accredited to carry out the conformity procedures for the Canadian market.

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How to achieve Canadian compliance?

The CSA marking certification process can be difficult to understand and the CSA certification cost depends on the particular service. Our team of experts at Certification Experts offer guidance and advice on compliance solutions Canada to ease this process and offer the following services:

To ensure that the product is found to be compliant for the Canadian market, Certification Experts offer a pre-project, TAS, prior to the final compliance procedure. The findings will be provided in a findings letter, which will be discussed with your company. If applicable, our experts will communicate required modifications to ensure a successful Canadian Field Certification. During this stage, our experts will work together with your company to come up with acceptable solution(s) for all parties in case of any non compliances.
Field evaluation is a process that is implemented in the field whereby unapproved products can be evaluated to the necessary requirements that are acceptable to the local Authority Having Jurisdiction (AHJ), owner or other regulatory body. It must then be evaluated to the applicable product safety standard(s) for the specific application and location where the product will be utilised. This process includes construction inspection for use of components, assembly and limited nondestructive testing to complete the assessment. Certification Experts can guide this process with the applicable NRTL.
Field certification is similar to the field evaluation, the difference is that the field certification will result in a certificate of conformity and the approval mark will indicate certified.
Limited Production Certification (LPC) which is recognized as Type 1 form of Limited certification service under the international ISO conformity assessment system and is accepted by accredited bodies. LPC is essentially a “batch certification” designed to accommodate situations where a limited quantity of the product is manufactured, or a batch of the product is intended for distribution. Certification Experts can guide this process.
Canadian Centre for Occupational Health and Safety (CCOHS) functions as the primary national agency in Canada to ensure safe and healthy workplaces and prevent work-related injuries, illnesses and deaths. Herein, Certification Experts can verify the requirements for your product, determine the safety status, provide advice and guidance regarding CCOHS and perform a risk assessment.
Innovation, Science and Economic Development Canada (ISED) is a certification that is required for radio technologies to be able to enter the Canadian market. Without this certification, market access onto the Canadian market for manufacturers of products with radio technologies is excluded. After the official certification of the device by the ISED, the approval is permanently valid. Therefore, recertification is not necessary if the device remains unchanged. In order to receive ISED approval, a Foreign Certifications Body (FCB) must conduct a findings report, and when compliance is determined, will issue an approval. Certification Experts can guide this process.
Interference-Causing Equipment Standard (ICES) entails the general requirements for compliance of interference-causing equipment. Interference-causing equipment is a device, machinery or equipment, other than radio apparatus or terminal equipment, that causes or is capable of causing interference to radio communication. Without this, market access onto the Canadian market for manufacturers of devices, machinery and/or equipment is not permitted. Certification Experts can guide you with the complete ICES conformity assessment procedures: certification procedure and Supplier’s Declaration of Conformity.

We can also help you get approved product for the following markets:

  • USA: certification UL
  • International: CB certification
  • Europe: CE Marking
  • UK: UKCA mark
  • China: CCC marking
CE Marking

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1 – Industrial

Industrial equipment and products used as work tools in work or a professional environment: are regulated by the Canadian Centre for Occupational Health and Safety (CCOHS).

2 – Electrical & Electronic

Electrical and electronic products susceptible to (unwanted) electronic emissions or electromagnetic interference: are regulated by the Dept of Communications within Canada and must be in compliance with ICES requirements.

3 – Medical Devices

Medical Devices: class I are regulated by the Medical Device Establishment License (MDEL) and class II, III and IV are regulated by Medical Device License (MDL).

4 – Consumer

Consumer products are regulated by the Canada Consumer Product Safety Act (CCPSA).

5 – Toy safety

Toy safety: regime is in effect under the Canada Consumer Product Safety Act (CCPSA). There are several regulations under the CCPSA that address specific hazards with children’s toys, the main regulation is the Toys Regulations (SOR/2011-17).

Services

Certification Experts offers the following services

Click on the service blocks below to see what our experts can do to help you obtain Canadian compliance.

Route to Compliance / Classification

For every market, Certification Experts can provide a practical compliance roadmap. This will ensure your access to any chosen market in the most time and cost-efficient way.  This service can entail a classification of relevant Product Safety Regulations, an assessment of the product, an analyze of the design, a verification of the used components, materials and a determination of the potential risks associated with its use.

  • Determining how the applicable product legislation applies to your product
  • Describing the steps of the conformity assessment procedure
  • Determining roles and responsibilities of the parties involved
  • Setting up test procedures

Engineering Review

Qualified engineers or experts of Certification Experts can carry out systematic examination of a product, system, process, design, or project, during the development phase. The purpose of an engineering review is to assess various aspects of the subject matter to ensure its functionality, safety, compliance with regulations, quality, and overall performance.

  • Design Review
  • Pre-compliance testing
  • Consultancy and assist in arranging the necessary product testing

Legal compliance guidance

In the contemporary landscape of rigorous business regulations, compliance matters often pose intricate and multifarious challenges. Our Legal Compliance Service is committed to furnishing the requisite support and proficiency essential for adeptly tackling these complexities. Whether you confront regulatory issues, customer conflicts, or issues related to competition, our team can provide expert guidance on every aspect of product compliance.

  • Authority letter (NVWA, NoBo, ILT and BPT)
  • Seller/buyer problem resolution 
  • Advise on Product Legislation
  • Legal Guidance
  • Compliance Solutions
  • Third-Party Communication
  • Issue Resolution

GAP Analyses 

A GAP analysis based on product specific regulations is a structured assessment that identifies the differences or “gaps” between a company’s current practices and the requirements stipulated by product safety regulations. This type of analysis helps organizations ensure that their products are compliant with the relevant safety standards and regulations. Certification Experts can carry out a GAP analysis based on the specific requirements  for organisations to ensure that their products meet safety standards and remain compliant with regulatory requirements. It helps mitigate risks, ensures consumer safety, and safeguards a company’s reputation in the marketplace.

  • Regulatory Framework Identification
  • Current Practices Assessment
  • Regulatory Requirements Evaluation
  • Gap Identification
  • Prioritisation
  • Plan of Action

Information and warnings for the end users

Certification Experts can provide help with the following to ensure that your manuals, labelling and packaging are fully compliant with your chosen markets.

  • Checklists
  • Product labelling
  • Templates
  • Drafting Manuals
  • Machine plate

CE Marking

The CE mark serves as proof that a product complies with European product regulations. It’s a mandatory requirement for manufacturers whose products fall under applicable CE directives and regulations before they can enter the European market. Additionally, other parties like importers, distributors, and authorized representatives have their roles in ensuring that products bear the CE mark. Obtaining CE marking can be a complex and time-consuming endeavor. It involves understanding regulatory requirements, accessing the necessary testing facilities, and managing time effectively. Our team of CE mark consultants is here to support you throughout this process. We’ll guide you, conduct the required testing, and simplify the path to obtaining CE marking for your products. As your dedicated compliance partner, we aim to streamline this often intricate procedure.

  • Conformity Assessement procedure
  • Technical File
  • Risk Assessment
  • Inspection/Safety Assessment
  • Testing
  • Declaration of Conformity
  • Authorised Representation

Declaration of Conformity

A Declaration of Conformity (DoC) is an official document in which the manufacturer declares that their product is in compliance with the essential requirements of the applicable European CE Directives and/or Regulations. Certification Experts has both the knowledge and international experience to help you draw up a suitable EU Declaration of Conformity for your product, thereby ensuring that your product is safe and will be able to enter the market.

  • Determine specific declaration of conformity requirements
  • Collect all necessary product information
  • Determine applicable directives and legislation
  • Draw up the Declaration of Conformity

Technical File 

A Technical File contains relevant information that should demonstrate that your product complies with the essential requirements as stated in the relevant directives and/or regulations. It is a mandatory component of demonstrating the conformity of your product. As your full-service compliance partner, Certification Experts can assist you in gathering all necessary information and preparing and composing the Technical File.

  • Evaluating, guiding and providing instructions for use
  • Evaluating, guiding and preparing Risk Assessment
  • Assemble Technical File
  • Drafting the Declaration of Conformity (DoC) template
  • Review user information

Risk Assessment ISO 12100

Carrying out a risk assessment is required according to the Machinery Directive (2006/42/EC). If you are unsure on how to carry out a risk assessment, Certification Experts supports you and provides full guidance.

  • ISO 12100:2010
  • Risk, Inventory and Evaluation (RI&E)
  • Verification and evaluation of existing risk assessment
  • Guidance in preparation of a risk assessment
  • Validation of safety functions
  • Execution of Performance Level (PL) and calculations of Safety Integrity Level (SIL)
  • Training in risk assessment and use of Safexpert software
  • Safexpert risk assessment software (TÜV certified)
  • On-site machine inspection
  • Risk assessment for Work Equipement Directive

Risk Assessment

The European Product Legislation requires manufacturers to incorporate a risk assessment of potential risks associated with their equipment into their technical file.  As stated in the directive an ‘adequate analysis and assessment of the risk(s)’  is required Certification Expert provides full guidance and execution of this requirement.

  • Execution of the risk assessment
  • Guidance in performing a risk assessment
  • Product testing and evaluation
  • Training in risk assessment and use of Safexpert software
  • Safexpert risk assessment software (TÜV certified)

Risk Management

The Medical Device Regulation (EU 2017/745),in Europe has a strong emphasis on Risk Management. Herein, manufacturers of medical devices must identify foreseeable riks and implement risk mitigation measures throughout the design and production process. However, it is important to note that assessing the risks does not end here, as ISO 14971:2019, titled “Medical devices – Application of risk management to medical devices” requires companies manage risks as an ongoing internal process that lasts throughout a medical device’s product life cycle. 

  • Execution of the risk assessment
  • Guidance in performing a risk assessment

Inspection/Safety Assessment

Certification Experts offer to carry out inspections/safety assessments based on European Product Legislation (CE Marking) to guarantee that products meet the necessary safety and quality standards for sale within the European market. Non-compliance can result in significant legal consequences, including product recalls, fines, and reputational damage. Therefore, it’s crucial for manufacturers to have a thorough understanding of the relevant directives and regulations, and to adhere to them to ensure compliance for their products.

  • Perform onsite inspection/Safety Assessment
  • Discuss pending queries
  • Verify potential hazards and risks 
  • Review draft Risk Assessment
  • Perform testing, based on the assumption all components are in compliance and the assembly will be tested when functioning as an integral whole 

Product Testing

Product compliance often requires product testing, a requirement determined by applicable legislation. Certification Experts specializes in product testing, offering in-house, on-site, and partner test lab solutions.

Our most common testing:

  •  EMC (Electromagnetic Compatibility)
  • Low Voltage / electrical safety
  • RoHS
  • Radio Equipment
  • Medical
  • Toys
  • Machinery
  • ATEX
  • Safety

Affiliate Notified Body Services

For higher risk products, the technical documentation must be reviewed and tested by a Notified Body (NoBo). Affiliate Notified Body Services involve organisations collaborating with designated Notified Bodies. This provides expertise, supplementary services, or support for product testing and certification and as a result, streamlines processes and enhances certification capabilities, ensuring products meet EU regulations. Certification Experts can guide this process and submit the documentation to the Notified Body, ensuring that the file is complete before the certification procedure. 

  • Search and selection of NoBo
  • Request quotations from NoBo
  • Guidance with application process with a NoBo
  • Supervising certification process with NoBo

Training Machinery

Certification Experts provides training for CE marking your machinery or installation, ensuring safe entry into the EU market.

  • CE marking
  • Machinery Directive (MD) and Machine Safety
  • Functional safety (PL & SIL) for machinery
  • Machine Safety Specialist with TÜV certificate
  • Safexpert software
  • Risk assessment
  • Work Equipment Directive

Training medical devices

Certification Experts offers training programs for CE marking and Quality Management Systems (QMS). This provides you with the knowledge on how to enter your medical device safely onto the EU Market.

  • Quality Management System ISO 13485
  • Medical Device Certification
  • Software IEC 62304
  • Technical documentation
  • GDP Training

Training CE marking process

Certification Experts offers training programs that will prepare you for the CE marking process of your  product.  

  • CE marking
  • Safexpert software

Functional Safety

Functional safety services play a critical role in minimizing risks associated with complex systems, particularly those involving human safety. They ensure that products and systems operate reliably, even in the presence of faults or failures, by employing a combination of engineering techniques, thorough testing, and adherence to safety standards. Certification Experts provides guidance, evaluation, training, and certification services to ensure that your control systems comply with the required safety standards according to EN-ISO 13849 and the Performance Level concept.

  • Calculations
  • Expert guidance and advice
  • Evaluation of safety functions
  • Training

Performance Level (PL)

Performance Level (PL) services involve assessing and ensuring the safety of systems by determining and achieving specific risk reduction levels defined by safety standards. These services cover risk assessment, design, analysis, testing, and certification to meet required performance levels. Certification Experts can assist companies in implementing and meeting these requirements according to the EN-ISO 13849 standard.

  • PL assessment and determination: Advice and implementation

Safety Intergrity Level (SIL)

Safety Integrity Level (SIL) is a concept used in functional safety standards like IEC 61508 and IEC 61511 to indicate the effectiveness of safety functions in reducing the risk of hazardous events. Certification Experts can support companies in implementing and complying with the Safety Integrity Level (SIL) standards, which are used for assessing and ensuring the safety of instrumental systems used in process industries. Our services involve activities aimed at assessing, designing, and verifying safety functions to meet the specified SIL requirements:

  • SIL assessment
  • SIL verification
  • SIL management and advice

Lockout-Tagout-Tryout (LOTOTO)

LOTOTO ensures compliance with safety standards and prevents accidents. Certification Experts can assist companies in implementing and complying with the Lockout-Tagout (LOTO) process, also known as Lockout-Tagout-Tryout (LOTOTO). Our focus is on safe equipment maintenance and our services involve clear procedures, using locks and tags to prevent accidental activation, documenting steps, training workers, and verifying isolation. Herein, we will conduct a baseline assessment regarding LOTOTO

  • Development of LOTOTO policies.

Working Equipment Directive 

Working Equipment Directive Services help businesses comply with EU regulations for machinery and equipment safety. These services include risk assessment, safety measures, training, maintenance, and documentation to ensure a safe workplace and legal compliance. Certification Experts will ensure  Workplace Equipment compliance as we specialise in helping businesses meet the requirements of this directive, ensuring the safety of your workplace equipment. 

  • Initial Assessment
  • Regulatory Analysis
  • Documentation Review
  • Risk Evaluation
  • Testing and Inspection
  • Training

Quality Management System

Quality Management System services help businesses establish and maintain effective quality management processes. This involves implementing procedures, training, auditing, and continuous improvement to meet customer expectations and industry standards. Our team at CE Medical (part of Certification Experts) can set up, implement, review and maintain a Quality Management System (QMS) for your organisation. Additionally, we can provide an appropriate QMS based on your situation and wishes.

  • ISO 13485
  • ISO 9001
  • Article 10 Quality Management System MDR

Registration Medical Device

Obtaining a medical device registration is mandatory under the Medical Device Regulation 2017/745 to achieve a safer and transparent market for the benefit of medical device end-users. Certification Experts can guide the registration of your medical devices within EUDAMED (previously Farmatec) for Europe  for the UK the medical device needs to be registered within the MHRA.

  • Classify your product 
  • Register as your EC REP/UKRP and you as manufacturer 
  • Obtain the correct marking for your product 
  • Guiding the UDI proces and guidance with the registeration of your products in EUDAMED and/or Notis (Farmatec), or with the MHRA

EUDAMED + UDI

CE Medical can assist with registering in EUDAMED and with UDI. EUDAMED is a European database for medical devices.  Regulation (EU) 2017/745 on medical devices and regulation (EU) 2017/746 on vitro diagnostic medical devices introduce an EU device identification system. It is based on a unique device identifier (UDI) and allows for easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Importers, authorised representatives and system/procedure packers must also register in EUDAMED. 

  • Registering in EUDAMED as an Authorised Representative (EC REP)
  • Guidance with EUDAMED registration of your company and medical devices
  • Guidance with UDI System

Certificate of Free Sales

Certificate of Free Sale (CFS) is a vital certification for the manufacturers of medical instruments to do business in open market. When exporting a medical device, CFS is an additional requirement needed by manufacturers to ensure that they the device is already available in the market of exporting country (where the manufacturer is based). On behalf of the manufacturer, an Certification Experts can as Authorised Representative submit an application to a European Competent Authority to issue CFS.

  • Submit application
  • Legalisation at embassy 
  • Legalisation at Apostille

PRRC

Certification Experts can offer to act as a Person Responsible for Regulatory Compliance (PRRC) in the context of medical devices. . The PRRC is a crucial role mandated by the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to ensure compliance with regulatory requirements for medical devices and in vitro diagnostics. Certification Experts can also act as the Deputy PRRC. A Deputy PRRC, or Deputy Person Responsible for Regulatory Compliance, is an individual appointed by a medical device or in vitro diagnostic device manufacturer to assist the PRRC in fulfilling their duties related to regulatory compliance.

  • PRRC
  • Deputy PRRC
  • Guiding PRRC and/or Deputy PRRC

Low Voltage Directive

Certification Experts possesses the knowledge and capability to effectively guide and support you in navigating all aspects related to Low Voltage, ensuring compliance with the Low Voltage Directive (LVD). 

  • LV Advice and Assessment
  • Technical File Preparation
  • Risk Assessment and Safety Evaluation
  • LV Testing
  • User Information and Labeling
  • CE Marking and EU Declaration of Conformity

ATEX

Certification Experts can offer a wide range of services related to ATEX (ATmosphères EXplosibles) – the European directives for explosive atmospheres to ensure compliance. This includes expertise in assessing and certifying equipment intended for use in potentially explosive atmospheres, ensuring compliance with relevant safety directives and standards.

  • ATEX Advice and Assessment
  • Risk Assessment and Classification
  • Technical Documentation and Conformity Evaluation
  • ATEX Consultancy

Pressure Equipment

Certification Experts can provide a range of services related to the EU Pressure Equipment Directive (PED). This includes assessing and certifying pressure equipment, ensuring adherence to the Pressure Equipment Directive’s safety and quality requirements, which encompass aspects such as design, manufacturing, materials, testing, inspection, and documentation for pressure equipment. These requirements are meant to ensure that the equipment is built to withstand the intended operating conditions and to mitigate potential risks of failures, leaks, or explosions.

  • PED Compliance Assessment
  • Technical File Preparation
  • Risk Assessment and Safety Evaluation
  • CE Marking and Declaration of Conformity
  • CE Marking and Declaration of Conformity

Construction Products

Certification Experts can provide a range of services regarding the Construction Products Regulation (CPR) services. This includes evaluating and certifying construction products’ performance and safety in accordance with European Union standards. These services ensure that products used in construction projects meet specified requirements for characteristics such as fire resistance, structural integrity, and environmental impact. Here are some of the services they can offer:

  • Product Category Determination
  • CPR Compliance Assessment.
  • Technical Documentation Preparation
  • Assessment and Verification of Performance
  • Testing and Performance Evaluation
  • User Information and Labeling
  • CE Marking and Declaration of Performance
  • Notified Body Interaction

Personal Protective Equipment

Certification Experts can provide a comprehensive range of services tailored to assist with compliance to the EU Personal Protective Equipment (PPE) Regulation. This regulation governs the design, manufacturing, and marketing of personal protective equipment within the European Union. 

  • PPE Category Determination
  • Technical Documentation Preparation
  • Conformity Assessment Procedures
  • Risk Assessment and Safety Evaluation
  • Testing and Evaluation
  • User Information and Labeling
  • Notified Body Interaction
  • CE Marking and Declaration of Conformity

Toy Safety

Certification Experts can provide a variety of services tailored to assist with compliance to the EU Toy Safety Directive, which establishes safety standards for toys sold within the European Union. These services assess factors like materials, design, choking hazards, and overall safety to ensure that toys are suitable for children and do not pose any risks to their health or well-being.

  • Classification
  • Product Categorization and Age-Appropriateness
  • Technical Documentation Preparation
  • Safety Assessment and Risk Evaluation
  • Testing
  • CE Marking and Declaration of Conformity

Measuring Instruments

Measuring Instruments Services involve tasks that uphold the precision and reliability of measurement tools used across industries. This guarantees accurate readings, verifying their accuracy, and performing maintenance and repairs, and assures that measurements align with recognized standards, enabling quality assurance, regulatory compliance, and effective decision-making in diverse sectors. Certification Experts can provide a variety of services tailored to assist with compliance to the EU Measuring Instruments Directive (MID), which sets out the requirements for the design, manufacture, and conformity assessment of measuring instruments placed on the market within the European Union. 

  • Instrument Classification and Verification Methods
  • Technical Documentation Preparation
  • User Information and Labeling
  • MID Compliance Assessment
  • Conformity Assessment Procedures
  • Testing and Verification
  • Notified Body Interaction
  • CE Marking and Declaration of Conformity

GPSD General Product Safety Directive

Certification Experts can offer a variety of services related to the EU General Product Safety Directive (GPSD), which aims to ensure the safety of consumer products placed on the market within the European Union. The GPSD has been designed to guarantee the safety of those products that do not fall within the domain of CE marking before they can be placed on the European market and/or used. For products for which specific directives and/or regulations already exist regarding the guarantee of safety, the general product safety directive only applies to the aspects of risks and risk categories that are not described in those specific directives and/or regulations.

  • Justification General Safety Directive/Regulation
  • Technical Documentation
  • Conformity Assessment Procedures
  • Risk Assessment and Safety Evaluation
  • Testing and Evaluation
  • User Information and Labeling
  • Declaration of Compliance
  • Recall Procedures

Ecodesign

Certification Experts can provide a variety of services to assist with compliance to the EU Ecodesign Directive, which aims to improve the environmental performance of energy-related products placed on the market within the European Union. Here are some of the services they can offer:
Ecodesign Directive Compliance Assessment: Certification Experts can assess your energy-related products to determine their conformity with the requirements outlined in the EU Ecodesign Directive.

  • Product Categorization and Energy Efficiency Requirements
  • Energy Labeling and Information Requirements
  • Ecodesign Impact Assessment
  • Technical Documentation Preparation
  • CE Marking and Declaration of Conformity

E-Commerce 

Certification Experts can assist you in selling your product on on-line platforms, such as Amazon and Bol.com. As an Importer or Private Labeller, you have an obligation to ensure that your product is safe and poses no risk to the consumer or end user. This must be demonstrable, and therefore, you need access to the Manufacturer’s Technical Documentation.

  • Identifying the applicable Directive(s) and/or Regulation(s)
  • Identifying related harmonized standards
  • Verifying the existing documentation
  • Assessing whether the existing documentation demonstrates product compliance with the applicable requirements
  • Providing advice and recommendations
  • Initiating contact with the Chinese Supplier (one-time communication)
  • Drafting the Declaration of Conformity format
  • Creating a Private Label Contract

International Market Access

International Market Access Services help businesses expand their global operations. Certification Experts provide specialised knowledge in regulatory compliance, certifications, and local prerequisites. These services aid in customizing products and strategies for new markets, building distribution networks, and mitigating potential risks. Certification Experts can provide valuable guidance for international compliance assessments, ensuring your products meet global standards and enabling their entry into international markets or specific regions.

  • Consultancy
  • Route to compliance
  • Testing
  • On-site inspections
  • Design Review
  • Technical File Review
  • Risk Assessment
  • Training

USA Compliance (UL standards)

US Compliance encompasses stringent criteria for safety, quality, and sustainability, which encompass product certification, testing, audits, sustainability verification, and regulatory counsel. These measures are implemented to foster consumer confidence and uphold the highest industry standards. Certification Experts provides comprehensive support and expert assistance to ensure your equipment complies with US regulations and UL standards, facilitating its entry into the US market.

  • Determine applicable product standard
  • Documentation review
  • Technical Advisory Service (TAS)
  • Guidance towards testing
  • Field evaluation and certification
  • Guidance with NRTL-procedure
  • Guidance with limited product certification

Canadian Compliance (CSA)

Canadian (CSA) compliance services are important in industries where safety, reliability, and consumer trust are paramount, such as electrical and electronic products, appliances, industrial equipment, and more. These services help businesses demonstrate their commitment to safety and quality while enabling them to navigate complex regulatory landscapes. Certification Experts offers complete guidance and expert services in order to ensure your equipment is compliant with Canadian legislation to be able to enter the Canadian market.  

  • Determine applicable product standard
  • Documentation review
  • Technical Advisory Service (TAS)
  • Guidance towards testing
  • Field evaluation and certification
  • Guidance with NRTL-procedure
  • Guidance with limited product certification

UK Compliance (UKCA)

UKCA compliance services are essential due to the UK’s departure from the EU. After Brexit, products entering the UK market must adhere to the UKCA marking standards to demonstrate compliance with local safety and performance regulations. These services ensure that businesses can continue selling products in the UK, maintain consumer trust, and navigate the updated regulatory environment effectively. Certifications Experts will help you enter the UK market with your products. We offer complete compliance guidance and expert services in order to ensure your product is compliant with the UKCA marking legislation. 

  • Consultancy and advice on problem solving
  • Stipulate route to compliance 
  • Determine the applicable standards, directives and regulations
  • Guiding the conformity assessment procedure
  • Perform product testing
  • On-site inspections 
  • Design review 
  • Support with technical documentation
  • Perform risk assessment
  • UKCA Declaration of Compliance
  • UK Authorised Representation (UKAR)/ UK Responsible Person (UKRP)

Chinese Compliance 

Chinese compliance is necessary to meet China’s unique regulations. This includes certifications, import/export, market entry, cultural adaptation, quality inspections, IP protection, and government relations. These services are essential for success and compliance in the Chinese market. At Certification Experts, we have a Chinese office where our partners are able to offer guidance and advice on compliance solutions for China trade compliance.

  • CCC
  • CQC
  • NMPA
  • SELO
  • SRRC
  • RoHS

CB Scheme

The CB Scheme simplifies global market entry. This includes standardised testing and certification that is recognised by multiple countries. Benefits of becoming CB compliant involves reduced testing redundancy, efficient certification, cost savings, and consistent quality assurance. Certification Experts offers guidance regarding the CB scheme to be able to access multiple markets. 

  • Apply the CB scheme
  • Cooperation with National Certification Body (NCB) and Certification Body Test Laboratory (CBTL)
  • Arrange CB testing
  • Guide CB scheme process
  • Ensure CB certificate

Technical Compliance Review (TCR)

Certification Experts offers a pre-project: a Technical Compliance Review (TCR), prior to the compliance procedure. The TCR is based on technical documentation and an initial inspection of the equipment. The findings of the TCR will be provided in a findings letter by the NRTL (National Recognized Testing Laboratory). In collaboration with all applicable parties involved, the required modifications will be stipulated to ensure a successful compliance procedure. ​

  • Documentation review
  • Review of critical components based on the Bill of Materials (BOM)
  • Equipment inspection
  • Findings letter
  • Guidance prior to the compliance procedure

Field Evaluation or Certification

Field Certification (FC) – also called Unit Verification, is an internationally recognized form of certification under the ISO conformity assessment system and is accepted by the accreditation of professionals. An FC will be conducted for each individual product or batch on location, including a one-time test. Certification Experts can guide this process.

  • Collaboration with the NRTL
  • Perform a final electrical safety test
  • Final inspection of the equipment
  • Labelling will be provided; including official documents wherein approval of the label is stated

Limited Product Certification (LPC)

Limited Product Certification (LPC) is essentially a “batch certification,” designed to accommodate situations where a limited quantity of the product is manufactured, or a batch of the product is intended for distribution. After verifying that all units in the batch are identical to the test sample and in compliance, they are labeled on location by a NRTL representative, using a serialized certification. Certification Experts can guide this process. 

  • The product is tested and evaluated to the appropriate standards at the NRTL laboratory
  • Labelling batch on location

OSHA

OSHA aid businesses in maintaining workplace safety and compliance with regulations. This includes assessments, training, guidance, hazard mitigation, recordkeeping, inspections, and fostering a safety culture to protect employees and ensure legal adherence. These safety requirements apply to machines, devices and equipment for the professional market. Certification Experts can ensure your products meet these requirements and the Occupational Safety and Health Administration (OSHA) monitors compliance with this.

  • Verify the OSHA requirements
  • Determine safety status according to OSHA requirements
  • Provide advice and guidance regarding OSHA
  • Perform risk assessment

FCC

FCC certification is required for a manufacturer in order to obtain market approval in the US for a device with wireless technologies. In order to obtain market approval, a manufacturer must conduct the FCC certification procedure. Certification Experts can provide aid with this. 

  • FCC Testing
  • Certification (47 CFR Section 2.907)
  • Declaration of Conformity from Supplier (47 CFR Section 2.906)

FDA

Certification Experts has an affiliated partner in the USS who can guide the FDA Compliance for Medical Devices.
Our partner is specialized in helping medical device manufacturers meet FDA requirements efficiently. From documentation to testing, he has got the expertise to guide companies through every step, ensuring market approval.

CPSIA and ASTM

All children’s products, including furniture, in the US, targeted to children below the age of twelve years old, are subjected to the regulations of CPSIA.  
All manufacturers, importers, and distributers of children’s furniture and other child related products must ensure that their products are compliant with all related ASTM substance restrictions and standards. Certifications can provide aid with verifying the compliance of this.

CCOHS

Safety requirements apply to machines, devices and equipment for the professional market. The Canadian Centre for Occupational Health and Safety (CCOHS) monitors compliance with this. Certification Experts can ensure your products meet these requirements in order to guarantee compliance with CCOHS. 

  • Verify the CCOHS requirements
  • Determine safety status according to the CCOHS requirements
  • Provide advice and guidance regarding CCOHS
  • Perform risk assessment

ISED

Certification Experts can guide with complying with ISED (Innovation, Science and Economic Development). These regulations involves several key steps to ensure that electronic and wireless devices meet the necessary requirements. ​

  • Product Classification under ISED’s regulatory framework.
  • Radio Equipment Certification
  • Testing and Evaluation
  • Technical Documentation
  • Declaration 
  • Registration with ISED
  • Labeling Requirements
  • Submission and Approval

ICES

Being ICES compliant is important as it prevents interference with other devices, meets regulations like CRTC mandates, builds consumer trust, avoids penalties and recalls, enables global market access, and enhances industry reputation. Certification Experts can guide to comply with ICES (Interference-Causing Equipment Standard) regulations in Canada ensure that electronic or electrical equipment doesn’t cause interference with radio communications and other devices.

  • Determine if equipment falls under the scope of ICES regulations
  • Testing and Evaluation
  • Technical Documentation
  • Declaration
  • Labeling Requirements
  • Registration (if applicable)
  • Submission and Compliance Verification

Canadian Medical Devices Regulation (CMDR SOR/98-282)

Manufacturers intending to obtain a Medical Device License for medical devices classified as II, III, or IV are required to demonstrate adherence to the Canadian Medical Devices Regulation (CMDR SOR/98-282). Manufacturers of Class I devices that are not sold directly to the consumer must acquire a Medical Device Establishment License (MDEL). The MDEL requires companies to have documented procedures in place that meet the CMDR related to distribution records, complaint handling, recalls, incident reporting, and (as applicable) for handling, storage, delivery, installation, servicing and corrective action. Health Canada periodically inspects MDEL holders to ensure these procedures and records are maintained.

CCPSA and Toys Regulations

Canada’s mandatory toy safety regime is in effect under the Canada Consumer Product Safety Act (CCPSA). There are several regulations under the CCPSA that address specific hazards with children’s toys, the main regulation is the Toys Regulations (SOR/2011-17). Certifications can provide aid with verifying the compliance of this. 

  • Product Classification
  • Testing and Evaluation
  • Risk Assessment
  • Technical Documentation
  • Declaration 
  • Labeling Requirements
  • Notification and Reporting

UK Authorised Representation

UKCA Experts (part of Certification Experts) act on behalf of a manufacturer established outside of the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations we operate in various sectors such as Machinery, Electronics, Medical Devices, Consumer Product, Toys, Personal Protective Equipment, Boats and more. 

  • Aid in UKCA marking conformity assessment procedure
  • UKRP agreement/mandate
  • Technical file and documentation review
  • Acting as a contact person with the competent authorities
  • Providing legal advice

UK Responsible Person (UKRP)

As of Brexit, the MHRA requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative UK for manufacturers of Medical Devices and will generally fulfil the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). They are a registered legal party based within the UK that acts as a liaison between a manufacturer outside of the UK and the MHRA. UKCA Experts (part of Certification Experts) act on behalf of a manufacturer established outside of the United Kingdom as their UKRP.

  • Aid in UKCA marking conformity assessment procedure
  • UKRP agreement/mandate
  • Technical file and documentation review
  • Acting as a contact person with the competent authorities
  • Providing legal advice
  • MHRA Registration

UKCA Declaration of Conformity

A UKCA Declaration of Conformity is an official document in which the manufacturer declares that their product is in compliance with the essential requirements of the applicable UKCA Statutory Instruments. This document is mandatory as it is necessary to be able to acquire UKCA marking. Certification Experts has both the knowledge and international experience to help you draw up a suitable UKCA Declaration of Conformity for your product, thereby ensuring that your product is safe and will be able to enter the market.

  • Determine specific declaration of conformity requirements
  • Determine applicable UKCA Statutory Instruments
  • Collect all necessary product information
  • Draw up the UKCA Declaration of Conformity

CQC

Products which are not in the compulsory certification catalogue and cannot receive a CCC Certificate (China Compulsory Certificate) have the option to apply for a voluntary product certification. This CQC Mark Certification is a voluntary product certification. Our Chinese office offers guidance on cost and time efficiency regarding certification to be able to access the Chinese market through obtaining the CQC mark certification.  

  • Selection of the relevant Chinese GB/T standards
  • Documentation investigation
  • CQC application
  • Testing by CQC

SELO

  • Apply to special equipment license 
  • Accept Application or refuse application 
  • Type examination 
  • Issue type examination report 
  • Apply qualification review and submit required documents 
  • Issue qualification report 
  • Issue special equipment licence or disallowance notice 

SRRC

SRRC services are essential for businesses aiming to sell wireless and radio products in China. This involves navigating regulations, streamline certification procedures, and ensuring products meet the required technical standards while adhering to radio frequency regulations. Products that use WLAN or bluetooth  require a State Radio Regulation Certificate. This must be carried out in a test laboratory in China. At Certification Experts, we have a Chinese office that can provide guidance and advice regarding this process.  

  • Application
  • Type examination 
  • Issue type examination report
  • Issue type examination report
  • Submit required documents
  • Review required documents 
  • Issue SRRC certificate 

Restriction of Hazardous Substances (RoHS)

In order to ensure the absolute compliance of your electrical and electronic products, the Administrative Measure on the Control of Pollution caused by Electronic Information Products must be examined.  Restriction of Hazardous Substances (ROHS) compliance is essential as it protects the environment by restricting hazardous substances in electronics, which minimizes ecological impact. This compliance also assures consumer safety and worker well-being by ensuring products are free from harmful materials. Beyond legal mandates, ROHS adherence is pivotal for market access, preventing barriers to entry. Moreover, it builds consumer trust, enhances brand reputation through ethical practices, and promotes innovation in creating safer and more sustainable electronic products. At Certification Experts, we offer RoHS compliance services.

  • RoHS Testing
  • RoHS verification based on components
  • RoHS Compliance

NMPA

Medical device and IVD manufacturers will need to obtain National Medical Products Administration (NMPA) approval to bring their product onto the Chinese market. At Certification Experts, we have a Chinese office who offers guidance and advice on compliance solutions in order to obtain NMPA certification. Certification Experts can be your agent and assist you with registering in NMPA. 

  • Classification
  • ISO 13485 
  • Application NMPA
  • Format inspection by NMPA
  • Technical review
  • Review and decision
  • Decision delivery by NMPA
  • NMPA Agent

QMS

CE Medical can set up, implement, review and maintain a Quality Management System (QMS) for your organisation. We provide an appropriate QMS based on your situation and wishes.

  • ISO 13485
  • vISO 9001
  • Article 10 Quality Management System MDR

ISO 13485

Our team of experts can aid in helping you to achieve the ISO 13485 QMS  and ensure  that your company meets the requirements that ensure that your medical devices and services consistently meet customer expectations and relevant regulatory requirements.

  • Gap Analysis
  • Set up a quality system
  • Implementation session with presentation
  • Training ISO 13485, risk management and internal audit training 
  • Internal audit 
  • Support with certification audit 
  • Maintenance of QMS

ISO 9001

Our team of experts can aid in helping you to achieve the ISO 9001 QMS  and ensure  that your company meets the requirements that ensure that your devices and services consistently meet customer expectations and relevant regulatory requirements.

  • Gap Analysis (see what you have and what you still need)
  • Setting up a Quality Management System (QMS) with all applicable procedures, work instructions, standard forms and supporting documentation
  • Implementation session with presentation
  • Internal audit training and risk management training (optional)
  • Internal audit – checking if the QMS has been implemented well and according to the ISO 9001 requirements
  • Support with the certification audit (accredited Certification body for ISO 9001 certification) 
  • Maintenance of QMS

Art. 10 of MDR

Our team of experts can aid in helping you to achieve the Article 10 of MDR requirements. This article outlines the requirements for the QMS that all manufacturers must follow in order to be able to put their product or service into the market. Our team of experts can aid in helping you to implement the applicable QMS according to Article 10 of MDR and guide you through this process. 

  • Gap Analysis (see what you have and what you still need)
  • Set up a quality system with all applicable procedures, work instructions, standard forms and supporting documentation according to article 10
  • Implementation session with presentation
  • Internal audit – checking if the QMS has been implemented well and according to the standard 
  • Maintenance of QMS

Internal Audit

Our team of experts can provide aid via the Testing of your management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit.

  • Internal Audit

Management Review

Certification Experts will support the management in assessing the effective operation of the quality management system and help identify opportunities for improvement and risks.

  • Management Review

Certification Audit

Certification experts will support with certification audit. During the on-site audit our experts will provide on-site support to assist with any queries that arise during the audit. With our guidance, companies can approach the QMS certification audit with confidence, knowing that they are well-prepared and supported every step of the way.

  • Advise and support during certification audit

Non-Conformance Procedure

A Non-Conformance Procedure within a Quality Management System (QMS) is a structured and documented process that outlines the steps to be taken when a non-conformance is identified within the organization’s quality processes. A non-conformance refers to any instance where a product, process, or activity does not meet the specified requirements, standards, or expectations.

  • Identifying and documenting the non conformity (With evidence/proof in the form of photos)
  • Root Cause analysis of the con conformity (by applying the 5 way method or the Ishikawa method (fishbone)
  • Corrective and preventive actions  (CAPA’s)
  • Preventative actions which will stop the non conformance from occurring again
  • Effectiveness check on the taken actions
  • Close out signatures once both or all parties have  rectified and closed the non conformance

QMS Maintenance 

The basis of a quality management system is the continuous improvement and optimisation of the organisation. Once the certificate has been obtained, the quality must be continuously maintained. By engaging with our Medical Team, you can enhance the effectiveness of your QMS, maintain compliance with regulatory standards, and ensure the continued safety and quality of your medical devices in the market.

  • Maintenance QMS

GDP 

GDP is an abbreviation of Good Distribution Practice and refers to the EU-guidelines that have been created to ensure the product safety and product quality of medicinal products within the full supply chain, from manufacturer to patient, and to prevent counterfeit products. To ensure that you meet all the requirements, we will help you implement a suitable and complete GDP QMS. Additionally, we will perform internal audits to verify the compliance. We will train and support your RP, help you with temperature mapping, and set up a risk assessment for your GDP processes. Our (field) experience and expert knowledge will allow us to ensure that you will acquire the GDP license and eventually GDP-certificate, so you can safely trade your medicinal products within the EEA. 

  • GDP GAP Analyse 
  • GDP QMS
  • Wholesale License
  • Temperature Monitoring 
  • Management Review 
  • Self-Inspections/Internal Audits 
  • Training 
  • Guidance for IGJ Inspection 
  • Role Responsible Person

GDP QMS

Certification Experts can set up, implement, review and maintain a Quality Management System (QMS) for your organisation based on the GDP requirements. We provide an appropriate QMS based on your situation and wishes.

  • GDP QMS
  • Update of QMS
  • Maintenance QMS

Wholesale License

A Wholesale License for Good Distribution Practices (GDP) is a regulatory authorization or permit that is typically issued by government health agencies or regulatory bodies to wholesalers and distributors involved in the distribution of pharmaceuticals, medical devices, and related healthcare products. This license ensures that the wholesale distribution of these products adheres to specific quality and safety standards to safeguard the integrity and efficacy of healthcare products as they move through the supply chain. 

  • GDP Licences
  • Maintenance GDP Licence
  • Check application form

Temperature Monitoring

Part of the GDP is implementing temperature monitoring devices, such as data loggers and real-time monitoring systems, to continuously track temperature conditions during storage and transportation. These devices should be calibrated and validated regularly. Before starting operations, it’s important to conduct temperature mapping studies of storage areas and transportation vehicles. This involves placing temperature sensors at various points to ensure that the entire area maintains the required temperature range consistently.

  • Temperature Mapping
  • Temperature Records
  • Develop Standard Operating Procedures (SOPs) 
  • Training

Training GDP

Training in Good Distribution Practice (GDP) is crucial for individuals and organizations involved in the distribution of pharmaceutical products to ensure that products are handled, stored, and transported in a manner that maintains their quality, safety, and efficacy. GDP training is typically a regulatory requirement in many countries and regions. Certification Experts have experts who are able to provide a GDP-training.

  • GDP training and exam
  • Internal RP basic training

Guidance for IGJ Inspection 

The ultimate goal of an IGJ Inspection is to verify that pharmaceutical distributors and wholesalers are following the established GDP guidelines to maintain the quality, safety, and integrity of medicinal products. Non-compliance can lead to regulatory actions, including warnings, fines, suspension, or revocation of licenses, depending on the severity of the violations. Certification Experts can facilitate the process to ensure the inspection goes smoothly. 

  • Guidance for IGJ Inspection

Responsible Person (RP) GDP

Certification Experts can offer to act as a Responsible Persons and will focus on helping pharmaceuticals fulfil their regulatory responsibilities and ensure that pharmaceutical products are distributed in compliance with GDP standards. These services are essential for maintaining the quality, safety, and efficacy of medicinal products as they move through the supply chain.

  • Set-up roles of RP and Deputy RP
  • RP service
  • Deputy RP service       
  • Guiding RP and/or Deputy RP                                                                                                 

EU Authorised Representation

AR Experts (part of Certification Experts) can act as an authorised representative on behalf of your organisation and ensures that the products being sold on the EU market comply with the European product compliance legislations. This concerns products that are sold either directly, via e-commerce (online), or through a fulfilment service provider. 
We operate in various sectors, such as Machinery, Electronics, Medical Devices, Consumer Product, Toys, Personal Protective Equipment, Boats and more. 

  • Aid in CE marking conformity assessment procedure
  • Authorised representative agreement/mandate
  • Technical file and Documentation review
  • Acting as a contact person with the competent authorities
  • Provide legal advice

EC Rep

According to the Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746) you are obliged to appoint a European Authorised Representative (EC REP) if you want to trade your Medical Device(s) on the European market. AR Experts (part of Certification Experts) can act as an EC REP on behalf of your organisation.

  • Aid in CE marking conformity assessment procedure
  • Authorised representative agreement/mandate
  • Technical file and Documentation review
  • Acting as a contact person with the competent authorities
  • Provide legal advice
  • Registering the manufacturer’s devices in EUDAMED

Mandate for Authorised Representation

AR Experts (part of Certification Experts) will set up the required mandate/agreement, herein it is determined which responsibilities/tasks of the manufacturer are mandated to the EUAR, UKAR, EC Rep and/or UKRP. This is based on the applicable directives and regulations. 

  • EU Authorised Representative agreement (mandate)
  • UK Authorised Representative agreement (mandate)
  • EC Rep agreement (mandate for medical devices)​
  • UKRP agreement (mandate for medical devices)​

AR services private labeller

You can only appoint an EUAR/UKRP if you are a manufacturer. If you are a reseller, it is necessary to become a private labeller in order to appoint an EUAR or a UKRP. When placing a product on the market under a private label, you will be considered as the legal manufacturer. This means that you will bear all the obligations of a manufacturer and can appoint AR Experts (part of Certification Experts) as your EUAR/UKRP.  

  • Setting up a private label agreement with the Original Equipment Manufacturer (OEM)
  • Aid in CE/UKCA marking conformity assessment procedure
  • Authorised representative agreement/mandate
  • Technical file and documentation review
  • Medical device registration
  • Acting as a contact person with the competent authorities
  • Provide legal advice

Authorised Representation

AR Experts (part of Certification Experts) can act as an authorised representative on behalf of your organisation and ensures that the products being sold on the EU and/or UK market comply with the applicable product compliance legislations. This concerns products that are sold either directly, via e-commerce (online), or through a fulfilment service provider. 
We operate in various sectors, such as Machinery, Electronics, Medical Devices, Consumer Product, Toys, Personal Protective Equipment, Boats and more.  

  • EU Authorised Representative
  • UK Authorised Representative
  • EC Rep (Medical Devices)
  • UK Repsonsible Person (UKRP)
  • Responsible Person (RP) GDP
  • Person Responsible for Regulatory Compliance (PRRC)

Declaration of Compliance

While the Declaration of Conformity serves as an official document linked to CE marking and adherence to precise directives and regulations, the Declaration of Compliance is an optional statement that focuses more broadly on the safety of consumer products, often aligning with the General Product Safety Directive. Certification Experts has both the knowledge and international experience to help you draw up a suitable Declaration of Compliance for your product, thereby ensuring that your product is safe and will be able to enter the market.

  • Determine specific Declaration of Compliance requirements
  • Determine applicable standards
  • Collect all necessary product information
  • Draw up the Declaration of Compliance

Recall Procedures GPSD

A recall procedure based on the General Product Safety Directive (GPSD) is a structured process for removing or correcting consumer products that pose a risk to the health and safety of consumers. The GPSD is a European Union directive that sets out general safety requirements for consumer products, and it places an emphasis on monitoring and taking corrective actions when unsafe products are identified. Certification Experts help businesses to navigate the complex process of product recalls in compliance with the GPSD, ensuring the safety of consumers and legal adherence.

  • Assistance in developing a comprehensive recall plan
  • Expert guidance on ensuring that the recall process complies with GPSD and any other relevant regulations
  • Liaison with authorities

Electromagnetic Compatibility (EMC)

Certification Experts possesses the knowledge and capability to effectively guide and support you in navigating all aspects related to Electromagnetic Compatibility (EMC), ensuring compliance with the EMC Directive. 

  • EMC Advice and Assessment
  • Technical File Preparation
  • Risk Assessment and Safety Evaluation
  • EMC Testing
  • User Information and Labeling
  • CE Marking and Declaration of Conformity

Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) 2017/745, effective since May 26, 2021, imposes stricter requirements on medical device manufacturers. Certification Experts, with over 25 years of experience, can assist in MDR compliance.

  • Legal risk classification of medical devices
  • GAP Analysis MDR + MDD to MDR
  • GAP Analysis QMS
  • Templates Technical File and QMS
  • Guidance, implementing and assessing QMS
  • Guidance and/or Review Technical File
  • EC Rep / UKRP
  • PRRC
  • Risk Management
  • Consult with Expert

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NMPA Agent

Certification Experts have the capability to serve as NMPA agents. China’s NMPA (National Medical Products Administration) holds the responsibility for overseeing the regulation and oversight of pharmaceuticals and medical devices. The National Medical Product Administration (NMPA), formerly known as CDFA, mandates that foreign manufacturers without a legal presence in China must designate a China Agent when initiating the product registration process.

  • NMPA agent​
  • Registration at NMPA

CAPA

To enhance quality and regulatory compliance, implementing an effective Corrective and Preventive Actions (CAPA) process is vital. Certification Experts’ consultants, with their expertise in quality management and regulations, play a crucial role in managing CAPA. Their knowledge aligns CAPA processes with standards like ISO 13485, ensuring compliance and proactive problem-solving. Engaging our experts streamlines CAPA procedures, optimizing workflows, and enhancing operational efficiency and customer satisfaction.

  • Identify and document the problem
  • Analyse the root cause
  • Determine immediate corrective action
  • Propose corrective measures
  • Assist in implementing the corrective action
  • Aid in monitoring and measuring effectiveness through performance indicators and measurable objectives
  • Report evaluation results to relevant stakeholders

Capa Training

Our service offers customised CAPA training for medical devices, led by expert instructors. We focus on regulatory aspects such as ISO 13485, share best practices, and provide interactive sessions with practical scenarios.

  • CAPA Training
  • CAPA discussion

Machine Safety EN ISO 12100:2010 

Learn about the NEN EN ISO 12100:2010, a European standard ensuring machinery safety by regulating the design process. Discover the principles of risk assessment, risk reduction, and the necessary steps for compliance to safely market machines within the EU. Get expert guidance for implementing ISO 12100 effectively.

Legal Compliance Service

Performance Level

Working Equipment Directive

Medical Device Single Audit Program (MDSAP)

Regulatory Compliance

Frequently asked questions

All the answers you might need!

CSA certification is generally not widely accepted in the United States. In the U.S., product certifications are often based on standards developed by organisations such as Underwriters Laboratories (UL) or other Nationally Recognized Testing Laboratories (NRTLs). These organisations establish standards that are widely recognised and accepted in the U.S. market.

While CSA is a respected certification organisation, its certifications may not automatically fulfill the requirements for product entry into the U.S. market. If you intend to sell or distribute products in the U.S., it is advisable to check the specific requirements and standards recognised by U.S. regulatory bodies and seek certification from relevant organisations that hold recognition in the U.S. market.

Obtaining a CSA certificate is not a legally mandatory marking, but a voluntary certification. However, many manufacturers choose to obtain and affix a CSA marking as it is a third-party organisation that is highly recognizable from a consumer standpoint, and thereby they also assume the responsibility for if anything goes wrong.

CSA (Canadian Standards Association) marking is primarily associated with Canada, where CSA standards are widely recognised and utilised to ensure the safety, performance, and sustainability of various products and systems.

While CSA marking is commonly linked to Canada, it’s important to note that certain products with CSA certification might also find acceptance in the United States and other international markets. The CSA Group collaborates with other standardisation bodies, and in some instances, their certifications may extend beyond Canada.

However, for products intended for markets outside of Canada, it is crucial to verify the specific standards and requirements of those regions. In the United States, for instance, products may need to adhere to standards established by organisations such as Underwriters Laboratories (UL). Always confirm the particular certification and marking prerequisites applicable to the target market where you plan to sell or distribute your products.

CSA (Canadian Standards Association) certification in Canada involves adherence to specific requirements outlined by the CSA Group. The requirements can vary depending on the type of product or system being certified.

There are many CSA standards to proof compliance with the specific requirements. Below are some of the many products that are often CSA certified based on CSA Certification Canada Requirements:

  • Electrical components
  • Electronic equipment
  • Wire and cable
  • Appliances
  • IT
  • Fire protection and fire suppression equipment
  • Signalling alarms
  • Equipment for use in hazardous locations

However, it is important to note that being CSA certified is not mandatory, therefore a Certificate of Compliance Canada is not required.

CSA is an abbreviation for Canadian Standards Association. The CSA marking is considered to be the equivalent of the CE mark, which is used in the European Union, and the CSA standards and approval marking are used in Canada. The CSA registered mark indicates that a product has been independently tested and the certification CSA has been performed to meet recognized standards for safety or performance.

To enter the Canadian market, you need to ensure the safety of your products/services and obtaining the CSA certification can proof Canadian compliance. The CSA mark indicates that the product, process, and service have been tested according to Canadian standards and comply with these standards. Full safety compliance is achieved by adhering to measures set to assess and certify product safety in accordance with federal regulations and national codes. However, the marking is not a legally mandatory designation unless mandated by a government or established in a mandate by an industry or trade association.

CSA publishes standards in print and electronic form given in the CSA marking certificate Database. Furthermore, CSA provides training and advisory services. CSA is composed of representatives from industry, government, and consumer groups. Herein, they offer CSA product certification for electrical products, mechanical products, or ‘at risk’ ones in general. The CSA logo indicates that the product, process and service have been tested according to Canadian standards and that they comply with requirements of this standard.

Testimonials

What our clients are saying about us

Gallery Play Media

Ruben Kieftenbelt CTO
Our experience with Certification Experts was pleasant and valuable. The test results during the certification project were comprehensive and detailed and they swiftly offered solutions when there were obstacles.

Nikon

Joachim Hofmann GM Service & Support
Collaboration with the Certification team has been very helpful, professional, fast and flexible. It is always good to have a partner at hand who can help with profound expertise whenever required. We look forward to collaborating for our future endeavors!

Physee

Wai-Man Tang Quality Assurance Manager
We have a wonderful experience working with Certification Experts. We are a scale-up company that specialises in doing product developments under a very tight timeline, and the team expertly adjusts to our needs and guides us step by step!

Dot Robot

Edward Belderbos Technical Director
It was a pleasure to work with Certification Experts. After reviewing our documentation, they gave us structured feedback and showed us how to proceed in order to be in compliance with European directives.

Noffz

Markus Solbach Director Sales & Marketing
Certification Experts offers great service with high flexibility and a fast response time. Their technical understanding and detailed feedback to our complex test solution in a short timeframe is impressive!

Government of Canada

Melanie Ter Meulen Trade Comissioner
Certification Experts is a valuable partner to us. The collaboration runs smooth and if Dutch companies require specific technical information, Certification Experts is able to provide this.

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

Fette Compacting Belgium BV

Kris Schoeters Technical Sales Support & Project Management
The team at Certification Experts ensured a new way forward for the Fette Compacting team, wherein they ensured a higher level of safety for our operators.

Nutek

Marc Schaerlaeckens Managing Director
Certification Experts made sure to consider every possible phase of CE marking processes, ranging from how to make the right design choices to composing a technical file.

Oceanteam

Lars van ‘t Kruijs Managing Director
The team at Certification Experts provide excellent cooperation! They provide detailed explanations and think-along solutions.

Confocal.nl

Peter Drent CEO
Personally, I am very satisfied with the service and quality of the work of Certification Experts. I certainly intend to work with them for future projects!

Adtrackmedia

Paul East CTO
Certification Experts has been helpful, knowledgeable and prompt – even during difficult circumstances surrounding the pandemic. We look forward to working with Certification Experts on future projects.

Alfa Wassermann

Kurt Spiegel Vice President of Engineering
Certification Experts has been our partner for over 10 years and the relationship is outstanding. They’ve completed CE Marking, UKCA Marking, and act as our Authorized Representative. The face-to-face meetings are really important and save us a lot of time!

Bondtech Corporation

Elsa Brown President
For more than 15 years, Bondtech has had the pleasure of being partnered with Certification Experts for CE marking for Europe and the UKCA for the UK. Their professionalism, rapid responses, and attention to detail impressed us. Their tailored guidance and meticulous review of our specifications ensured compliance with CE directives. In addition to conducting the conformity assessment process for us, they also act as our Authorised Representative. We recommend Certification Experts for their expertise and personalized service, which not only secured our certifications but also provided invaluable support.

New Compliance

Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Safexpert Review 1

For us Safexpert is the ideal tool for risk assessments and CE-documentations. The structuring of plant-projects gives us the possibility also to handle big/complex projects in a clear and structured way. But also for Risk assessments for machinery outside Europe Safexpert is a very helpful tool.

Safexpert Review 2

A good software for safety analysis and risk assessment.

Safexpert Review 3

A straight one, easy to use program with many options.

Safexpert Review 4

A versatile program for the entire CE process.

Safexpert Review 5

Useful software to get CE marking. It saves a lot of time.

Safexpert Review 6

A program which helps you to get into the labyrinth of CE norms.

Safexpert Review 7

Seems to be a very strong and structured product to do Risk Assessment and CE marking.

Safexpert Review 8

A powerful and helpful program.

Aria Technologies

Omar Ahmed Senior QA/QC Engineer
Certification Experts facilitated us to obtain the CE mark for our Cartesian Robot, enabling us to access the European market. Their clear communication and personalized approach made our collaboration a pleasant experience.

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