Startup Basics

U.S. Food and Drug Administration Rules for AI in Medical Devices (SaMD)

AI is moving into hospitals fast. It reads scans, flags risks, guides doctors, and watches patients from afar. But in the U.S., you cannot ship AI for health care just because it “works.” If your software helps diagnose, treat, prevent, or even guides a clinical decision, the Food and Drug Administration (FDA) may treat it

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Model Cards and System Cards for Real-World Compliance

Most founders I meet are not trying to “move fast and break things.” They are trying to ship something real—into hospitals, factories, banks, schools, or government systems—without getting blocked by legal, security, or trust reviews. That is where model cards and system cards earn their keep. Think of them as the plain-language “truth document” for

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Bias Testing That Regulators and Buyers Expect

Bias testing used to be something teams talked about “later.” After launch. After growth. After the first big customer. That is not how it works anymore. If you build AI that touches hiring, lending, insurance, health, education, safety, public services, or even basic customer support, people will ask the same hard question early: “How do

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