DEKRA Product Testing
Want to be assured of global market access for your electrical medical devices?
DEKRA Product Testing
Want to be assured of global market access for your electrical medical devices?
Medical device certification
Testing and certification to international safety standards
Electrical medical devices must be safe for both the user and the patient. With medical device certification you give patients and medical professionals assurance of the safety and effectiveness of your products. Have your products tested at DEKRA's accredited laboratories to demonstrate that your products comply with strict standards and regulations that apply to medical devices.
IEC 60601
is one of the most important standards for the certification of medical devices. This international standard contains a set of technical requirements for the safety and essential performance of electrical medical devices. In most markets it is mandatory to comply with this widely accepted standard.
Medical device certification by DEKRA allows you to demonstrate that your medical device meets all safety requirements. Curious about our accredited scope for medical device testing?
Medical device certification in 7 steps
The medical equipment certification process
DEKRA is your partner for medical device certification. As a manufacturer or designer, you know your product best. We know the medical device standards in detail. For almost 100 years, DEKRA has been one of the largest players worldwide in the field of testing and inspection. In addition, our experts have years of experience in medical equipment certification. At DEKRA, you are assured of a reliable and fast process.
Optional next steps
Getting your medical electrical equipment certified for access to global markets is no easy task. We guide you through the certification process from start to finish in each of the seven steps. After your device or product has been certified by DEKRA, the following steps may also be necessary:
Notified Body
Obtain regulatory approval through DEKRA's Notified Body. Please note that regulatory approval may run in parallel with our compliance testing procedure for safety and EMC & Wireless testing.
Benefits of medical equipment certification through DEKRA
Accredited Test Laboratorium (CBTL)
Our testing laboratory in Arnhem is accredited by the Dutch Accreditation Council (RvA). You can be sure that we have extremely high standards for the work of our technicians, our reports and project management. Besides our laboratory in Arnhem, we have several laboratories worldwide that you can visit when needed. Medical device certification at DEKRA is possible all over the world.
Centralized approach
DEKRA's extensive portfolio allows you to entrust all your testing procedures to one partner. With this centralized approach you benefit from:
- a central point of contact;
- fast communications lines;
- minimal transportation of samples;
- openness about non-conformity;
- an extremely short time-to-market.
Extensive scope
We provide support for ISO 17025 safety standards and CB certification. If required, we can expand the scope on the basis of long-term cooperation. Take advantage of a free session with one of our experts to discuss your specific medical equipment certification needs.
Request a session
Certification programs for various markets
Are you planning to introduce your product to the US or Canadian market? We are accredited as a Nationally Recognized Testing Laboratory (NRTL) based on our cDEKRAus quality mark. In other words: we take care of you from A to Z.
View an overview of all product certificates
Focus on partnership
We assist our customers throughout the entire medical device certification process. This results in a relationship characterized by mutual trust, openness and reliability.
EMC and cybersecurity
Our state-of-the-art laboratory in Arnhem offers extensive testing options in the field of electromagnetic compatibility (EMC) and cybersecurity.
Take the first step towards certification
Get in touch with an expert
Medical device certification FAQs
What technical documentation is prepared for my certification?
When preparing technical documentation for compliance with the essential performance requirements of Directive 93/42/EEC (MDR), we check whether medical devices meet the criteria of:
- IEC/EN 60601 (standards for electrical medical equipment)
- IEC 62304 (Lifecycle of medical device software)
- IEC 62366 (usability of medical devices)
- ISO 14971 (risk management for medical devices)
How can I prevent non-conformity?
How much does medical device certification cost?