Expert Advice Community

Guest

Can the same set of documents be used for the new company?

  Quote
Guest
Guest user Created:   May 31, 2019 Last commented:   May 31, 2019

Can the same set of documents be used for the new company?

We have an old medical device company and it produces products right now and we open another one but its very far from the old one we can give it the same name of the old company and make this like extension,and if its okay and we going to produce the same products of the old one we have not to make a new technical file and documents for the new company ?
0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law May 31, 2019

Answer:

You can use the existing technical file and documents for the same product that you will be producing in the new company.

For more information, please read article:

How to meet ISO 13485:2016 requirements for medical device files
https://advisera.com/13485academy/blog/2017/06/28/how-to-meet-iso-13485-requirements-for-medical-device-files/
Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

May 31, 2019

May 31, 2019