Functional Safety

Achieve Regulatory Compliance and Ensure Product Reliability with Comprehensive Functional Safety Services
  • Essential for compliance with international safety standards
  • Mitigates risks associated with electronic and automated systems
  • Required for certifications such as CE marking, ISO 26262, and IEC 61508
  • Ensures safe operation of machinery, medical devices, automotive systems, and more
  • Full-service support from Certification Experts’ dedicated team of engineers and compliance specialists

What is Functional Safety?

Functional Safety is a critical aspect of overall product safety, focusing on the correct functioning of electrical, electronic, and programmable systems to ensure that potential risks are reduced to an acceptable level. It is an integral component of industries such as automotive, medical devices, industrial automation, and consumer electronics, where failure of these systems could lead to hazardous situations.

Functional safety is governed by various international standards, including ISO 26262 for the automotive industry, IEC 61508 for general functional safety, and IEC 62304 for medical devices. These standards define the requirements for designing, developing, and maintaining safety-related systems, ensuring that they operate correctly even under fault conditions. Achieving compliance with functional safety standards is essential for obtaining certifications such as CE marking and for ensuring that your products are safe and reliable in the market.

The Importance of Functional Safety for Product Development

In today’s increasingly automated world, the complexity of systems and their reliance on electronics and software have grown exponentially. Functional safety ensures that these systems are designed to operate safely, even in the event of a failure, thereby protecting users, operators, and the environment. It is a mandatory requirement for many industries, particularly those where safety is of paramount importance.

Here are some key benefits of implementing functional safety:

  1. Functional safety is required to meet international standards like ISO 26262, IEC 61508, and IEC 62061. Compliance with these standards is often necessary for obtaining certifications such as CE marking, which is mandatory for many products in the European market.
  1. By adhering to functional safety principles, manufacturers can identify and mitigate potential risks early in the design process, reducing the likelihood of system failures that could lead to accidents or hazardous situations.
  1. Functional safety ensures that products operate reliably, even under fault conditions, which is crucial for maintaining customer trust and avoiding costly recalls or legal issues.
Compliance with functional safety standards is often a prerequisite for entering regulated markets, especially in sectors like automotive, medical devices, and industrial machinery.

How to Achieve Functional Safety?

Achieving functional safety involves a systematic approach that spans the entire product lifecycle, from design and development to validation and maintenance. Certification Experts provides end-to-end support to ensure that your products meet all necessary functional safety requirements, helping you navigate the complexities of international standards and achieve compliance efficiently.

Risk Assessment and Hazard Analysis

The first step in achieving functional safety is conducting a thorough risk assessment and hazard analysis. This involves identifying potential risks associated with the product and determining the safety functions required to mitigate these risks. Certification Experts’ team of engineers and safety specialists works closely with you to perform a detailed analysis, ensuring that all potential hazards are identified and addressed.

Safety Requirements Specification

Once the risks have been identified, the next step is to specify the safety requirements for the product. This includes defining the safety functions, performance levels, and system architecture needed to ensure that the product operates safely under all conditions. Certification Experts helps you develop a comprehensive safety requirements specification that aligns with the relevant functional safety standards.

System Design and Development

With the safety requirements in place, the product can be designed and developed to meet these specifications. This includes implementing the necessary safety functions, conducting fault analysis, and validating the system’s performance under various conditions. Certification Experts supports you throughout the design and development process, ensuring that your product is built to meet the highest safety standards.

Validation and Verification

Validation and verification are critical steps in the functional safety process. These steps involve testing the product to ensure that it meets the specified safety requirements and that the safety functions perform as intended under all conditions. Certification Experts coordinates the validation and verification process, working with accredited testing laboratories to ensure that your product is fully compliant with the relevant standards.

Safety Documentation and Certification

Comprehensive documentation is essential for demonstrating compliance with functional safety standards. This includes maintaining detailed records of the risk assessment, safety requirements, design specifications, and test results. Certification Experts assists you in compiling and organizing this documentation, ensuring that it is readily available for regulatory reviews or audits. We also guide you through the certification process, helping you obtain the necessary certifications for market access.

The Role of Certification Experts in Functional Safety

Navigating the complexities of functional safety standards requires deep expertise and experience. Certification Experts offers comprehensive functional safety services, providing the guidance and support you need to ensure that your products are safe, reliable, and compliant with international standards.

Our services include:

  •  We conduct thorough risk assessments to identify potential hazards and determine the necessary safety functions.
Our team helps you develop detailed safety requirements that align with the relevant functional safety standards.
We support you throughout the design and development process, ensuring that your product meets the highest safety standards.
We coordinate testing and validation efforts to ensure that your product complies with all applicable functional safety requirements.
We assist in compiling and maintaining comprehensive safety documentation and guide you through the certification process to achieve compliance.

By partnering with Certification Experts, you can be confident that your products will meet the rigorous requirements of functional safety standards, ensuring safe operation and reliable market access.

Full-service product compliance

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frequently asked questions

All the answers you might need!

Certification Experts offers comprehensive functional safety services, including risk assessment, safety requirements specification, system design support, validation and verification, and assistance with safety documentation and certification.

Achieving functional safety involves conducting a risk assessment, specifying safety requirements, designing and developing safety functions, validating and verifying the system, and maintaining comprehensive safety documentation. Certification Experts provides full support throughout this process.

Functional safety is crucial in industries such as automotive, medical devices, industrial automation, and consumer electronics, where the failure of systems can have serious safety implications.

Functional safety is necessary to comply with international safety standards such as ISO 26262 and IEC 61508. It ensures that products operate safely, mitigating risks associated with system failures that could lead to hazardous situations.

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What our clients are saying about us

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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.

Full-service product compliance

Leave it to us.

ISO 9001 Certified
ISO 27001 Certified
ISO27001 & ISO9001 certified – Trusted by 300+ Clients