Technical Documentation for the Medical Device Regulation (MDR) - International

A required part of conformity assessment and CE Marking is the need for technical documentation which includes the collation of supporting information about your medical device.

Technical documentation is maintained throughout the product lifecycle. Learn how to assemble this and other types of required information so you can CE Mark your device in Europe.

Prerequisites

You should have a basic understanding of European Medical Device Regulation (MDR).

Pedagogical objectives

  • Ensure auditable technical documentation meets regulatory requirements and demonstrates product safety and performance
  • Reduce delays to product certification by providing complete and compliant documentation
  • Reduce costs by reducing audit questions and nonconformities, thereby streamlining the certification process

These training modules are eligible to the subsidizing by the public institutions in France (OPCO);

*Each delegate receives a training convention after the enrolment.

**Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrolment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

***Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40

international training

Do you need more information?

If you have any concerns, please do not hesitate to contact our service department on the following numbers:

Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com


You will be put in touch with our team if necessary.

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