Greetings,
Is anyone able to provide me with some guidance regarding the level of detail for items in the 510k such as providing a summary of configuration management or maintenance activities?
For example, do we have to explain that maintenance activities are requested by internal/external customers, request is documented, goes for quality assessment, etc.
Any advise would be most helpful.
Cheers, Tonia
Is anyone able to provide me with some guidance regarding the level of detail for items in the 510k such as providing a summary of configuration management or maintenance activities?
For example, do we have to explain that maintenance activities are requested by internal/external customers, request is documented, goes for quality assessment, etc.
Any advise would be most helpful.
Cheers, Tonia