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Certificate of release/certificate of conformity/certificate of compliance


I work in quality assurance department for a start up medical device manufacturer. Can you please let me know after the medical device is built and tested does QA needs to issue Certificate of release/certificate of conformity or certificate of compliance before shipping the device to customer?

Hi, You must have release procedures in place, but there is no regulatory requirement for any form of certificate for medical devices. However, they are frequently used by customers to avoid the need for goods-in testing. You may want to check if it is a customer requirement.
Thanks chris1price for the response. It does make sense. I know for pharmaceuticals the customer do goodsin inspection and to avoid that they ask for certificate of release but am not quiet sure for medical device.


Starting to get Involved
Hi All,

I've tried to follow all the inputs regarding C of Cs, and couldn't find this answer. We are a manufacturer of PCBAs. One of our customers were reviewing our quality documents and made the comment that the CofC from one of our authorized component distributors did not have a signature on it. Most if not all our CofCs from component distributors come as part of the their packing slip. I have never seen a signed CofC from electronics parts distributors. Help!
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