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
Caroline Ehrenborg, Senior Quality and Regulatory Consultant
Dates and location
Lund
To be decided / On request
Stockholm
To be decided / On request
Online course
In co-operation with Swedish Medtech
To be decided / On request
Prices
SEK 5 500:-
For member companies to Swedish Medtech
SEK 3 900:-
All prices excl. local VAT.
Registration
The course is organised in collaboration with Swedish Medtech.
Do you want to know more about this course? You are welcome to contact QAdvis Academy at academy@qadvis.com.