Feedback between manufacturer and notified body on the CE marking process under the DM 2017/745 Regulation
i-Virtual, manufacturer of medical device software, organized on Tuesday, May 2nd, a webinar based on its experience regarding the submission, evaluation and audit of a technical file under the Regulation DM 2017/745.
Speakers at the webinar:
- i-Virtual,for the development and regulatory part of the medical device,
- RUMB, for the clinical part including sponsor and editor of the clinical evaluation,
- DNV, the notified body that evaluated and audited the technical file submitted by i-Virtual.
This webinar, mainly dedicated to the medical device industry, highlighted the steps involved in the CE marking process, what’s at stake and allowed us to answer all your questions.
You missed the webinar? Would you like to experience the session again?
The replay is available:
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