Electrical medical device testing and certification
Electrical Medical Devices need to be safe for both users and patients. Complying to the applicable standards proves that your product is widely accepted to be safe.
Complying with the essential performance standards protects you against unacceptable risk.
Complying with the standards from an early stage in your research and development process prevents costly redesigns and even more costly market withdrawals. DEKRA provides guidance for a First Time Right approach.
Testing against harmonized standards leads to easier access to markets around the world. As a global partner for safety, we are involved in international recognition procedures such as INMETRO and NRTL approvals.
Choose DEKRA for electrical medical device testing and certification
2. Accredited Test Laboratorium (CBTL)
3. Extensive scope
4. EMC, Wireless and RED
5. Technical documentation
6. Multi-market certification programs
- Intake – Define the roadmap to testing and certification
- Guidance - DEKRA works together with you to identify the applicable standards and provides testing and certification for (complex) electrical medical devices
- Engineering Review – DEKRA’s pre-compliance check forms the basis for gap analysis to identify possible non-conformities, not only within the electrical medical device, but also in the technical documentation, risk management, usability and software
- Gap Analysis – DEKRA gladly supports you by making a GAP-analysis between your current certification and the state-of-the-art 60601 standard, so it is clear what needs to be done to continue to comply with the standard.
- Testing and Certification – DEKRA’s experienced engineers will test your product according to the relevant standards and, when applicable, certify your product
- DEKRA Mark – The DEKRA Mark is a certification mark that demonstrates that your product has been thoroughly tested and meets all required safety standards. As the DEKRA Mark is based on internationally accepted and recognized standards, it is your product’s passport for worldwide market access.
Your roadmap to successful certification of your e-medical devices
Possible next steps:
- Regulatory approval: Obtain regulatory approval via DEKRA Notified Body. Please be aware that regulatory approval can run parallel and therefore simultaneously with our compliance testing procedure for safety and EMC & Wireless testing.
- Multi-market certification programs: With a CB Certification your product is ready for a smooth certification process in other parts of the world outside of Europe. For example, if you want to sell your electrical medical devices in the US or Canada, our NRTL-accredited laboratory is ready to help you with your CB-certification for the North-American market, the cDEKRAus product certification mark, INMETRO certification requirements and more.