FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)

Even seasoned regulatory professionals struggle to understand the myriad regulatory requirements pertaining to medical device software. A bewildering morass of national regulations, guidance, international standards, and overlapping documents make coding seem like the easy part. Fear not – in this article, we will give you a mountain-top view of your obligations and where to find the information you need to ensure a successful submission and ongoing compliance. Let’s start with US FDA requirements. How Does US FDA Regulate Medical Device […]

List (with Links) of Important Medical Device Software Standards

If you’ve done any research on regulatory requirements for medical device software, you know there is a bewildering array of documents out there covering everything from AI to UDI. Clients often ask us which documents are most relevant, so we’ve put together this list as a helpful resource. By all means, don’t assume this is a comprehensive list of every requirement related to software. The US FDA, for example, publishes 600+ medical device guidance documents, many of which are focused […]

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 […]

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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