Free MDR Online Seminar
Basics of Technical Documentation Part 2
Design Verification/Validation and Packaging
If you are aiming for MDR certification, you must create technical documentation. In the previous lecture "Basics of Technical Documentation Part 1," which was joined by more than hundred participants, we focused on the overview of technical documentation, GSPR, and risk management.
In the upcoming seminar, "The Basics of Technical Documentation Part 2," we will talk about verification, validation, and packaging, which are crucial points in medical device design.
DEKRA Japan reviewers, Hiroshi Yamada and Masaki Tsuda, will provide a detailed explanation on what notified bodies focus on in their reviews under the MDR.
This seminar is intended to provide a solid understanding of the basic concepts for those who are about to prepare technical documents. We also provide tips for those who have already prepared technical documents on how to update the documdents and ensure smooth communication with notified bodies.
Please see below for details of the seminar.
Date: 7 February 2025 (Fri)
Method: Online
Programme
15:00 – 17:00
Basics of Technical Documentation Part 2
- Design verification/validation and Packaging-
Lecturers: Hiroshi Yamada, Masaki Tsuda
*There will also be a Q&A session as time permits.
Date: 7 February 2025 (Fri)
Method: Online
Programme
15:00 – 17:00
Basics of Technical Documentation Part 2
- Design verification/validation and Packaging-
Lecturers: Hiroshi Yamada, Masaki Tsuda
*There will also be a Q&A session as time permits.
The final (third) session is to be "Basics of Technical Documentation Part 3 - Shelf life, Manufacturing information, Labeling". The date and time of the session will be announced later.
If you have any questions, please feel free to contact us at info.japan@dekra.com .
We look forward to seeing you at the seminar.
We look forward to seeing you at the seminar.