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Human Factors Evidence, Right-Sized: Reading FDA's 2026 Final Guidance

FDA's final guidance on human factors content in marketing submissions sorts devices into three categories. Here is how critical tasks and the use-related risk analysis decide how much evidence to submit.

Safety Risk vs. Cybersecurity Risk: Two Processes, One Device

ISO 14971 safety risk management and SW96 cybersecurity risk management answer different questions, but on a connected device neither is complete without the other. Here is where they differ, and exactly where they meet.

Why SBOMs Matter in the FDA-Regulated Environment

IEC 62304 Is Not Just a Checklist

Navigating MedTech: SiMD vs. SaMD – What’s the Difference?

Turning Oops into Opportunity: The Real Value of CAPA

Shifting Gears in Life Sciences: CSV vs. CSA Explained

CSV v CSA in the FDA context.