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Technology

Product Testing

Notified Body & medical device testing

Medical device technology

In recent years, the safety and quality of medical devices has become increasingly important, leading to stricter regulations, especially in the field of clinical trials. In addition, technological innovations are happening at lightning speed, linked to trends such as the interconnectivity of medical equipment.

All these developments mean that both the industry and Notified Bodies need to have increasingly specialized in-house knowledge to be able to meet the applicable requirements. With more than 25 years of experience and an extensive network of clinical experts, DEKRA has all the necessary knowledge to assess your medical devices, with patient safety as a priority.

In order to show compliance with the general safety and performance requirements of Annex I of the Medical Device Regulation (MDR) 2017/745, it is necessary to have an up-to-date technical file in place with regards to your medical device(s). It is the responsibility of the legal manufacturer to make the updated technical file available at any time. DEKRA Notified Body can assess compliancy with the Medical Device Regulation, whereas DEKRA Product Testing can test and certify your electrical medical device. For more information about DEKRA Notified Body, please click here .

IEC 60601 Electrical Medical Device Testing

The test reports and certificates for the applicable standards form a large part of this technical file. The 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment. These standards can be tested and certified by our accredited testing laboratories. We offer several services to guide you through this process, so that you always know where you currently stand and what still needs to be done to achieve full certification according to the (harmonized) standards. Alternatively, if you just want to test your electrical medical device according to specific standards for your own – and your customers’ – peace of mind, that can be done by partially testing your product against specific standards rather than full certification.

Discover our medical device Product Testing services

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Declaration of impartiality

We apply high standards, especially to ourselves

The DEKRA Certification B.V. top management declares the following commitment to impartiality: Our guiding principle is to fulfill and actively live the values which we look for at our customers. Only thus can we perform credibly as a service provider and role model with a customer-oriented approach. The basis for this is provided by our own management system and highest transparency internally and externally.

With the decisions they take in their daily activity, all the employees of DEKRA, including the Management Board, executives and staff, follow the principles of impartiality, objectivity and integrity.

- Bram Holtus, Managing Director

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