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Test medical devices for global market access

DEKRA Product Testing

Want to be assured of global market access for your electrical medical devices?

Electrical Medical Device Testing

IEC 60601 is the international standard for the safety and performance requirements for electrical medical devices. Find out, through DEKRA's expertise in testing and certification, how you can ensure the safety of your medical electrical equipment.

Electrical Safety Testing for Medical Devices

How do we test your electrical medical devices?

  • As an RvA approved testing laboratory;
  • Via IEC schemes as a certified body test lab (CBTL);
  • By offering a large scope including Electromagnetic Compatibility (EMC) and Radio Equipment (RED).

For our Notified Body services in accordance to the Medical Device Regulation (MDR), please click here.

6 reasons to choose DEKRA for testing your medical devices

1. Extensive scope

Our scope includes most safety standards for the ISO 17025 as well as for CB certification. DEKRA also carries out conformity assessment in accordance with IEC 62304 (software life cycle), IEC 60601-1-6 / IEC 62366 (usability) and ISO 14971 (risk management). If needed we can discuss a scope extension based on a long-term partnership.

2. Short Time to Market

Our facility and experience in this field speaks for itself. You are in good hands. As a manufacturer or designer you know your product best. We know the standards, have professional test facilities as well as experienced and qualified engineers to certify your products. This provides all the ingredients for a reliable, and fast track to market. After all, time is of the essence.

3. EMC & Wireless test labs

We have a well-equipped lab with comprehensive EMC & Wireless testing capabilities including 60601-1-2 for Medical Equipment, the Directives for Low Voltage and the RED. All from the convenience of our facilities located in Arnhem, The Netherlands.

4. Expert guidance

Together with the manufacturer, DEKRA identifies the applicable standards and provides testing and certification for (complex) Electrical Medical Devices. Our engineers are here to help you in this often complex process, via a pre-complaince check or engineering review.

5. Technical documentation

The DEKRA scope includes IEC 62304 (software life-cycle), IEC 60601-1-6 / IEC 62366 (usability) and ISO 14971 (risk management).

6. Certified Body Accredited Test Laboratory (CBTL)

We are an accredited test laboratory (CBTL) testing according to the CB scheme of the IEC standards.

Do you have a question? Get in touch with one of our experts

Tim van den Berg

Tim van den Berg

+31 88 96 83542

DEKRA Product Testing

Meander 1051

6825 MJ Arnhem

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