Technical documentation for medical devices

This event has expired
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
Recommended prior knowledge
The course is developed for participants who have a basic knowledge of MDD or MDR technical documentation.
Price
SEK 5 500:-
For member companies to Swedish Medtech
SEK 3 900:-
All prices excl. local VAT.
Information
- When: to
- Where: Online
- Organizer: QAdvis in co-operation with Swedish Medtech
- Language: Swedish
- Price: 5500 VAT not included
Registration
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