T
temujin
Morning,
One of our distributors in the US has requested that we include a "Certificate of Conformance" with each shipment which should
1) state conformance with the referenced (?) national and international standards.
2)That the items shipped were tested according to referenced drawings and standards.
This "Certificate of Conformance" should be lot-dependent.
The manufacture of this device is completely outsourced to a third company which is packaging and shipping directly to the distributor.
Could anyone tell me what such a "Certificate of Conformance" is? Is this something normally doe by Medical Device Manufacturers?
I´m confused as I believe any statement that the device conforms to the referenced standards are already in the "Declaration of Conformity". Why would we need to declare that each lot conforms to the given standard?
regards
t.
One of our distributors in the US has requested that we include a "Certificate of Conformance" with each shipment which should
1) state conformance with the referenced (?) national and international standards.
2)That the items shipped were tested according to referenced drawings and standards.
This "Certificate of Conformance" should be lot-dependent.
The manufacture of this device is completely outsourced to a third company which is packaging and shipping directly to the distributor.
Could anyone tell me what such a "Certificate of Conformance" is? Is this something normally doe by Medical Device Manufacturers?
I´m confused as I believe any statement that the device conforms to the referenced standards are already in the "Declaration of Conformity". Why would we need to declare that each lot conforms to the given standard?
regards
t.