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Dear Professionals
We are the medical devices company and implementing FDA QSR, As part of implementation, we need to implement complaint handling procedures.
Is there any different between customer feedback and complaint handling? If so
A significant compliant was received from the field regarding the performance of our device, this particular complaint was reported from a large number of customers.
What procedure do we follow to handle these complaints?
How would we decide whether to remove the affected device from the field?
I appreciate your valuable comments
-Sokku
We are the medical devices company and implementing FDA QSR, As part of implementation, we need to implement complaint handling procedures.
Is there any different between customer feedback and complaint handling? If so
A significant compliant was received from the field regarding the performance of our device, this particular complaint was reported from a large number of customers.
What procedure do we follow to handle these complaints?
How would we decide whether to remove the affected device from the field?
I appreciate your valuable comments
-Sokku
