Hi!
I am currently starting to implement a QMS i a MD repair company: no manufacturing, no design and development, only repairing MD for hospitals and clinics.
I have some questions because i am confused on how to comply with some requirements:
MD
I am currently starting to implement a QMS i a MD repair company: no manufacturing, no design and development, only repairing MD for hospitals and clinics.
I have some questions because i am confused on how to comply with some requirements:
- Which chapter of the standard can i exclude?
- Medical device file, as we do not own any MD, do we need to have a MD file? If yes, what information do we need to put?
- Risk management, many requirements are related to design or to MD itself. We have started to define some risks but most of them are general (organizational risks, supplier, etc.). Any example of risks related to a repair company?
MD