Technical documentation for medical devices

All medical devices sold in Europe must comply with relevant medical device regulations. Technical documentation is your proof of compliance. In this course, you will get to know more about how to avoid common mistakes and how to speed up the process of review and CE marking.

You will learn more about the requirements on technical documentation and what is expected from you as a manufacturer. After the course you will have the tools you need for managing a smooth third-party review and to avoid common mistakes.

Topics

• Why technical documentation?
• MDR Annex II
• MDR Annex III in short
• Do’s and Don’ts
• Recommendations of what needs to be checked before submitting to a Notified Body

Target group
This course is intended for quality and regulatory professionals working with medical devices and other medical device company employees who wish to learn about technical documentation.

Educational goals
After the course, participants will have a knowledge of technical documentation according to MDR, an understanding of how to avoid common mistakes and know the tools that are available for managing a smooth third-party review. After a successfully completed course, participants will receive a course certificate.

Recommended prior knowledge
The course is developed for participants who have a basic knowledge of MDD or MDR technical documentation.

Course presentations
Course material will be in English, verbal presentation and discussions in Swedish.

Course leader
Anneli Wiedenkeller, Senior Quality and Regulatory Consultant