Purpose and Outcome

This one-day course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe. The course is aimed at personnel involved in drafting technical documentation at manufacturers of medical devices.

Content

Upon completion of this training, you will be able to:

• Understand the technical documentation requirements as specified in the MDR and relevant guidance documentation
• Define the process enabling the creation and maintenance of technical documentation
• Understand how standards and guidance can be used to improve your technical documentation
• Recognize what is expected by Notified Bodies for technical documentation during reviews and be better prepared
• Recognize the documentation requirements during the product lifecycle and the post-market requirements

Who should attend

The course is relevant for product design personnel and QA/Regulatory personnel involved in drafting and compiling technical documentation.

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

Trainer

Bolette Nordby, Sr. Consultant and Owner, NOEI Medical Device ApS

What previous participants said 

"Liked the mix of slides and group work sessions"

"The structure was well aligned with the submission requirements"

"I appreciate the general overview as well as some tips and tricks that we were given"

"The course was quite interactive and the activities helped to understand the presentation and trigger interesting discussions with the participants"