QMS set up for manufacture of medical device

I want advice on setting up QMS. This is the scenario:
Company A: Has a ISO 13485 QMS for 'Design, Development and Manufacture of patient monitoring device'. Manufacture under non sterile conditions.
Company B: Wishes to set up manufacturing of wound care products. Manufacturing in ISO 7 (Class 10,000) clean room. Is it better (more economical, faster, and less cumbersome viz., documentation) to a. Get a separate certification for Company B or b. Outsource manufacturing for Company A to Company B and have the Scope for Company A's QMS modified.

Answer:

You should set up a separate QMS for Company B since the type of medical devices and scopes of the companies are entirely different.

Please refer to more information:

How to structure Quality Management System documentation according to ISO 13485
https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

Managing medical device infrastructure requirements according to ISO 13485:2016
https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/