Free MDR Online Seminar
Basics of Technical Documentation Part 1 -Overview of technical documentation, including GSPR and risk management-
Following the very well-received Clinical Evaluation seminars, we will hold, once again, a series of seminars on technical documentation. The first seminar will focus on General Safety and Performance Requirements (GSPR) and Risk Management, which have been requested by many participants, and we aim to present the participants overall understanding of technical documentation.
Among the requirements of the MDR, technical documentation is the most basic requirement, however, it is often difficult to know how far the manufacturer should take it. In this seminar, Mr. Hiroshi Yamada, a qualified and experienced technical file reviewer, will explain the requirements in detail from a practical perspective.
This seminar is intended to provide a solid understanding of the basic concepts for those who are about to prepare technical documents, and to provide tips for those who already have documents in hand on how to update them and facilitate smooth communication with notified bodies.
Please see below for details of the seminar.
Date: October 25, 2024 (Fri)
Method: Online
| Time | Program | Lecturer |
| 15:00 – 17:00 | Basics of Technical Documentation Part 1 -Overall view of technical documentation, GSPR and risk management- Lecturer: Hiroshi Yamada | Hiroshi Yamada |
From the second session onwards, we are planning the following (contents may be subject to change);
Part 2: Basics of technical documentation Part 2 - Design verification/validation and packaging-
Part 3: Basics of technical documentation Part 3 -Self life, Manufacturing information, Labeling-
Please register yourself to the seminar from the Google form below.
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.