Med Device Class for a Service Organization

#1
Has anyone experienced how you go about determining the medical device classification to pursue ISO 13485 for a service company? We perform a service to the medical device industry but, we do not manufacture widgets. looking for the How to?
 
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#2
You don't need a device classification for ISO 13485. Your scope of your certification would simply state what your role is as it pertains to 13485, and in your Quality Manual you would make sure you exclude or reference not applicable sections 13485. When you engage conversation with a registrar they can help with that to some degree. An example of a service for 13485 might be "calibration of XYZ for use in the medical device industry"
 
#3
You don't need a device classification for ISO 13485. Your scope of your certification would simply state what your role is as it pertains to 13485, and in your Quality Manual you would make sure you exclude or reference not applicable sections 13485. When you engage conversation with a registrar they can help with that to some degree. An example of a service for 13485 might be "calibration of XYZ for use in the medical device industry"
Thank you! @LUFAN
 
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