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hi my name is Helen and today were talking about how to document changes that are occurring to a medical device and how to assess their effect to the overall biocompatibility of the medical device a change in the biocompatibility world is considered an alteration of a medical device that stems from either at changing the materials that are used or processes I changed a decider location of the manufacturing process any changes occurring to the supply chain packaging service Asian and so forth as any of these changes could potentially affect that biocompatibility of your medical device is very important to evaluate the potential risks that are introduced to the medical device when its articling these changes it is very common to run into this problem when we have a medical device lets say this pen and it has already undergone all of the biocompatibility testing or evaluation and now we want to change the same material in one of its components or add a colorant for easier science recog
