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Service record requirements for Non-Serviceable Medical Devices

#1
Hi

Please help.

Suppose the device is class one category and will not be required any service after sold. So, as the device is non- serviceable, do I need to maintain any record?

Thanks in advance!

Regards
saurabh
 

yodon

Staff member
Super Moderator
#2
If you don't have any service, you couldn't have service records so there would be nothing to maintain.

You'll still gather postmarket data (complaints, returns, feedback, etc.) and use that in your ongoing assessments.
 
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