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Hello everyone,
we have a supplier of some critical part of our device (class III implant) which is not certified for ISO 13485. the component itself is pretty unique and 100% verification by us is not possible (for both budjet and professional issues). additional point is that the supplier does not agree to allow on-site audit for IP protection reasons. could certification for ISO 13485 solve this problem (than they should have all necessary processess in place to ensure conformance to our specifications and our receiving inspections could be based on CoC)?
Thanks.
we have a supplier of some critical part of our device (class III implant) which is not certified for ISO 13485. the component itself is pretty unique and 100% verification by us is not possible (for both budjet and professional issues). additional point is that the supplier does not agree to allow on-site audit for IP protection reasons. could certification for ISO 13485 solve this problem (than they should have all necessary processess in place to ensure conformance to our specifications and our receiving inspections could be based on CoC)?
Thanks.


