![]() The risk classification of a collection of medical devices that individually comply with all regulatory requirements depends on the product owner’s purpose in packaging and marketing. a physiological monitor and a separate recorder, or a general purpose syringe and a syringe driver). This is regardless of whether they are from the same product owner (e.g. If one medical device is intended to be used together with another medical device, the risk classification rules shall apply separately to each of the medical devices. ![]() conventional versus absorbable sutures).īased on the product owner’s intended purpose, if two or more risk classification rules apply to the medical device, the medical device is assigned the highest risk class. ![]()
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