Preparing Medical Device File
I like to prepare a medical device file from initial as i have starting manufacturing the medical device so please help me!!
Assign topic to the user
Technical documentation necessary for the medical device file is described in the Medical device regulation EU MDR 2017/745 in Annex 2 – Technical documentation and EU MDR Annex 3 – Technical documentation for post-market surveillance.
We in our ISO 13485 & MDR Documentation toolkit prepared the obligatory procedures and reports. Other test reports depend on the type of medical device and it was not possible to standardize it.
On the following link you can see the preview of those documents:
- Procedure for clinical evaluation and related documents https://advisera.com/13485academy/documentation/procedure-for-clinical-evaluation/
- Procedure for post-market surveillance and related documents https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/
-
Technical documentation procedure and related documents https://advisera.com/13485academy/documentation/technical-file-procedure/
For more information, see:
- EU MDR 2017/745 in Annex 2 – Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
- EU MDR Annex 3 – Technical documentation for post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/
Comment as guest or Sign in
Sep 11, 2020