Understanding IEC/ISO 62304 and FDA Requirements for Medical Device Software Development Life Cycle (SDLC) Management
Medical device manufacturers often hit roadblocks during FDA inspections or when it comes time to submit a 510(k) application for their device. Regardless of whether your device is considered software as a medical device (standalone SaMD) or software in a medical device (SiMD), there are specific steps that must be taken regarding change and risk management from the earliest stages of development to avoid running afoul of FDA requirements with respect to medical devices’ software development life cycle (SDLC). It […]
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