Software for Medical Systems
Any software used in a medical device must be built according to practices spelled out by the FDA’s Quality System Regulation (QSR). This paper discusses the verification, validation, and design control expectations of the FDA for approval of software in medical devices or used to manufacture medical products. It covers strategies for developing software for the three risk classes of devices, and provide examples of the sort of documentation necessary for either 510k or pre-market approval of medical software.
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