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I just started working for a contract manufacturing company that just started producing small diagnostic medical devices (class II). they have been asked by the owner of the device to participate in the design and engineering of the next generation of the device. but their ISO scope excluded design, I am updating the scope but in looking at the process they have in place, I am curious how a contract Manufacturer will perform a hazard ID or risk analysis of the device which will be put through the 510k process by the owning company (not us). My experience has been that the owning company would provide an initial hazard ID, do we as the manufacturer have any input into that process my first inclination is no as we are not deciding its us just implementing a request?.
My experience has been mainly as the OEM QA now I am the sub contractor QA and how do I integrate customer notification in bug testing or design problem solving? does that need to be documented in both systems?
we will be the manufacturer of the device should we have a full technical file at our disposal? what regulatory files?
My experience has been mainly as the OEM QA now I am the sub contractor QA and how do I integrate customer notification in bug testing or design problem solving? does that need to be documented in both systems?
we will be the manufacturer of the device should we have a full technical file at our disposal? what regulatory files?