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Part I: Medical Device Postmarket Change Controls and FDA 510(k) Software Modification Guidance

Part I: Medical Device Postmarket Change Controls and FDA 510(k) Software Modification Guidance

Part I: Medical Device Postmarket Change Controls and FDA 510(k) Software Modification Guidance

FDA's guidance on postmarket change controls for 510(k) software modifications ensures SaMD changes maintain safety and compliance.

Yu Zhao

2023年10月4日讀畢需時 5 分鐘

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