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- Navigating the New IGJ Guidance on Post-Market Surveillance
- Certification Experts Expands with New Office in Switzerland
- The New Machinery Regulation
- Certification Experts Expands its Services with the Acquisition of CEpartner4U
- Software as a Medical Device: smarter compliance with regulations
- Important Deadlines for EU MDR transition: Legacy Medical Devices to MDR Compliance
- Framework for Post-Market Surveillance (PMS)
- Who is responsible for the correct use of the CE mark?
- Expert Insights: US/Canada Product Compliance
- NEN-EN 1090, 1 July 2014
- The most efficient Risk Assessment with Safexpert
- EU MDR 2017/745 Notified Bodies Accreditation
- CE Marking vs USA Product Compliance: Here are the key differences
- Certification Experts joins Kader Group
- Experts Explain: The 5 steps to launch your product
- The revised guide to application of the Machinery Directive 2006/42/EC
- China: Long Term Strategy to Become World Leader in Technology
- CQC for Chinese Certification
- Construction Products Regulation 2013
- Rapex System – European Rapid Alert System for Dangerous Products
- CETA, Trade agreement between the EU and Canada
- Things to keep in mind for 2023!
- Radio Equipment Directive (RED) 2014/53/EU
- Brexit and Trading: Your Guide to CE, UKCA and UKNI Product Markings After the Brexit Transition Period
- Deadline for implementation ISO 13485:2016 quality management system
- Outsourcing your ISO 13485 Quality Management system?
- An A-Z Guide to Medical Device Regulations in the UK
- Face mask compliance during COVID 19: here’s what you should know
- European Ecodesign
- Obligations of the Importer CPR
- Use of nickel allowed in toys
- The CE Marking Process Explained
- Personal Protective Equipment (PPE) Regulation EU 2016/425
- Does private labelling still exist?
- Expert Insights: An engineer’s approach to CE marking machinery
- QMS ISO 13485 for Medical Devices
- China Medical Device Regulations
- 9 Interesting Facts about CE Marking
- The lifts and safety components of lifts Directive 2014/33/EU
- UKRP: Authorised Representative of the UK market
- CE Marking for Construction Products: Important facts
- Authorised representative for medical devices: a comprehensive guide
- Risk Assessment and the Low Voltage Directive
- New Regulation For the Machinery Directive in Europe
- CE Marking for Automated Material Handling Systems
- Expert Insights: All you need to know about Notified Bodies
- Brexit: Important Considerations for Medical Devices Exported to the UK from 1 January 2021
- Comprehensive Guide on European Authorised Representatives and the new Market Surveillance Regulation
- CE Marking: 5 frequently asked questions
- Certificate of Free Sales for Medical Devices: All You Need to Know
- 5 Facts You Should Know About Fulfilment Service Providers
- Updated list of standards, Machinery Directive
- What do you need to know about the New ATEX Directive 2014/34/EU?
- The Measuring Instruments Directive 2014/32/EU
- From CE to UKCA: What happens to Construction Products after January 2021?
- Important Safety Considerations for Electric Vehicles – Driving the Future
- 5 Important facts about Authorised Representatives
- Declaration of Conformity Template Method
- Worldwide Conformity Certification
- All you need to know about EU Authorised Representation
- Here’s what manufacturers should know about UKCA marking
- How to Draft Instructions for Use for CE Marking of Medical Devices
- The EU Market Surveillance Regulation: What is it and how can it affect your business?
- How Manufacturers Can Successfully Enter the Thai Product Market
- Updated EMC Directive 2014/30/EU List of harmonised standards
- National Medical Products Administration (NMPA)
- CE Certification for Medical Devices: Key Elements You Must Know
- Obligations of legal manufacturers of medical devices.
- The Electronics Industry and Product Safety: A One-Stop Guide for Businesses
- CE Marking in the World of Robotics
- Purpose of Certificate of Free Sale
- FDA and CE approval
- Most Common Electronic Product Certification and Compliance Requirements in the EU & USA
- The Importance of Product Safety – Essential Information For Any Manufacturer
- An Overview of Electronic Product Regulations in the United States
- Which-countries-and-areas-accept-the-CE-mark
- All you need to know about NRTLs
- Your Guide to European Compliance & Safety Standards for E-Bikes: “The Vehicles of the Future”
- Everything manufacturers need to know for CE certification of machinery
- Responsibilities of the manufacturer, importer, distributor and AR for CE-marking products
- Which information should be displayed on the machine plate?
- All you need to know about CE marking toys
- A Complete Guide to Medical Device Certification and Compliance in the European Union and the United Kingdom
- New Energy Labels from March 2021 – What is Changing?
- A complete guide to CE-marking and CB-certification of electrical equipment
- Understanding the difference between EU-Directives and EU-Regulations
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Knowledgebase
- CE marking product
- What is the specific role of an Authorised Representative?
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- CE Marking for Fire Doors
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- Which type of testing does my product require?
- What is a Notified body?
- CFDA updated Medical Device GMP certification
- What are the benefits of Self certification?
- What should be on the Declaration of Conformity?
- General safety and performance requirements Medical Devices
- If all components of my product are certified, do I still need to CE mark it?
- If the product has already been CSA approved, does this also apply in Europe?
- What is the difference between UKCA and CE marking?
- What is AR Experts?
- What are the disadvantages of Self certification?
- Which documents are in the Technical File?
- What should be on the product/type plate?
- Am I obliged to recertify my product, when a Directive, Regulation or standard is altered?
- What is the meaning of clustering a product?
- Which products can be certified with self-certification?
- How many standards are there?
- What is UKCA Marking?
- What is CE Medical?
- Summary EMC Directive 2014/30/EU
- Summary Measuring Instruments Directive 2014/32/EU
- There is a number on the Declaration of Conformity. Can the authenticity be proven by means of this number?
- The customs ask for an EC Declaration of Conformity. How do I get it?
- Which information should be in the user’s manual?
- NMPA China: Registration and medical device export
- Is it necessary for the packaging to possess CE certification as well?
- What costs can be expected for the CE-marking process?
- What should be put on the packaging when the product is certified?
- In which language should the Declaration of Conformity be drafted?
- Summary Low Voltage Directive 2014/35/EU
- Which countries belong to the European Economic Area (EEA)?
- Why is a EU/EC Declaration of Conformity required?
- When I modify my product should I re-certify again?
- What is the difference between Canadian (CSA) and USA compliance?
- What is an Authorised Representative?
- What documents are required for CE-marking?
- What is the difference between CE approval and CE marking for EU Directives?
- When I deliver components that will be built into an installation or a unit, must these also be CE-marked?
- Can I, the manufacturer, draft-my own EC Declaration of Conformity?
- CE marking refurbished or modified machinery
- How long does the CE marking process take?
- How can I verify whether the Declaration of Conformity is real?
- How long is a Declaration of Conformity valid?
- What is the difference between CCC and CE?
- How big should the CE logo be?
- Can I self-certify a product with CE-certification?
- What is the difference between CSA and CE?
- What is the difference between USA compliance and CE?
- What happens if my product is brought onto the market without CE marking?
Case Studies
Team
- Ferry van Bergen Henegouw
- Siebren Burghgraef
- Rebecca Brust
- René Zaat
- Richard Achterberg
- Arine Burema
- Wilma Hilhorst
- Huib Achten
- Emile Unk
- Annemieke van Kerkwijk
- Willemien van Rooijen
- Frank Lummen
- Richard Glaser
- Johan Deng
- Paul Williams
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