I'm preparing to get ISO13485 certified as Importer.
We are importing medical devices (class I) in Europe, implement warranty service and sell to EMEA/CIS area.
I know it's not a requirement to get ISO13485 as Importer but we should get it by main customer's request.
In this case, There are several questions I would like to ask.
1. How should I set the scope of ISO 13485 certificate? Development & Manufacturing will be excluded as we only implement procurement, sales, warranty service and storage.
2. How far should I create procedures? I don't think we need to conduct all the activities what ISO13485 requires.
3. For example to be more specific, how do we manage risk management?
Our headquarter(Legal Manufacturer) already conduct risk management activities and have relavent risk management files.
Do we have to make risk management procedure? can we just monitor those risk management files implemented by our HQ?
or do we have to do process risk assessment? (e.g. risk assessment for each procedure)
Your feedback would be very appreciated.