Expert Advice Community

Guest

Preparing Medical Device File

  Quote
Guest
Guest user Created:   Sep 10, 2020 Last commented:   Sep 11, 2020

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!!

0 0

Assign topic to the user

Assign

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Sep 11, 2020

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:

For more information, see:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Sep 10, 2020

Sep 11, 2020