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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FDA Oversight of AI and Machine-Learning Medical Devices

The application of artificial intelligence (AI) and machine learning (ML) in medical device software is moving at breakneck speed. Money is flowing into AI / ML start-ups, and the technology holds huge promise for its ability to predict, diagnose, and manage patient health conditions. Still, in the race to be first to market, it is easy for some start-ups to overlook the current ground rules for medical device regulation established by FDA. For many, FDA’s detailed requirements for design control […]

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EU MDR CER and EU IVDR PER for Software:
Understanding MDCG 2020-1

The EU Medical Device Regulation (MDR 2017/745) and EU In Vitro Diagnostic Regulation (IVDR 2017/746) put forward a multitude of challenges, chief among them the process of clinical evaluation. For medical device and IVD companies making products that incorporate software, the question of how much clinical evidence to gather can be perplexing. Rest assured that you are not the only one scratching your head. Many are apprehensive about how Notified Bodies will evaluate clinical evaluation reports (CER) or IVD performance […]

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Overview of Medical Device Cybersecurity Standards and Guidance Documents

UPDATED 2/2/2022 This is the final post post in a three-part blog series on risk management and cybersecurity. In our first post we review general risk management requirements for cybersecurity.  In our second post we discuss cybersecurity requirements for software and SaMD. If you are fairly new to risk management and cybersecurity compliance, you probably have noticed that there is a mind-boggling array of guidance and regulations online. Separating the “must have” from the “nice to have” can be as […]

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