Electrical medical device testing
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. This applies to both the user and the patient. With medical device certification you give patients and medical professionals certainty about the safety and effectiveness of your products. Through tests carried out in DEKRA's accredited laboratories, you demonstrate that your equipment complies with the 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.
Certification through DEKRA allows you to demonstrate that your medical device meets all safety requirements. Curious about our accredited scope for medical device testing?
Why certify through an accredited lab?
Objective assessment

An independent certification body ensures that your products are tested reliably and accurately.

Risk management

Compliance with the essential performance requirements helps you avoid unacceptable risks.

Cost reduction

By meeting the standards at an early stage of your R&D process, you avoid costly redesigns and even more costly recalls. DEKRA offers you the advice you need for a 'first time right' approach.

Global market access

Medical devices certification simplifies access to international markets. As a global security partner, we are closely involved in the development of international recognition procedures.

Benefits of certification through DEKRA

Experience and expertise

With DEKRA you are in good hands. As a manufacturer or designer, you know your product best. In turn, we know the standards like no other. For almost 100 years, DEKRA has been one of the largest players in the field of testing and inspection worldwide. In addition, our experts have years of experience in medical safety testing. This means that all the ingredients are present for a reliable and fast process.

Accredited Test Laboratorium (CBTL)

Our testing laboratory in Arnhem is accredited by the Dutch Accreditation Council (RvA). You can therefore be assured that we apply extremely high standards for the work of our technicians, our reports and project management. In addition to our lab in Arnhem, we have various laboratories worldwide that you can visit if necessary.

Extensive scope

We provide support for ISO 17025 safety standards and CB certification. If desired, 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 needs. Request a session

EMC and cybersecurity

Our state-of-the-art laboratory in Arnhem offers extensive testing options in the field of electromagnetic compatibility (EMC) and cybersecurity.

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 process. This results in a relationship characterized by mutual trust, openness and reliability.

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.

Medical device certification in 7 steps

The certification process

We will guide you step by step through this process, just as we have done for many other organizations that preceded you.

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 aid 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.

    Take the first step towards certification

    Are you also wondering what the road to certification looks like? Get to know DEKRA during a no-obligation session. Ask our expert anything you need to know about medical safety testing and get information about the relevant standards for medical electrical equipment.
    Enter your details here to schedule a session.

    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?
    Where are DEKRA certificates published?