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Why we built MDClassify

Figuring out the risk class of a medical device is usually the first question a manufacturer has to answer — and often the slowest, because it means booking time with a regulatory consultant just to get a preliminary read.

MDClassify runs the same Annex VIII logic a consultant would apply by hand, so you can get an indicative answer in minutes instead of days. It won't replace a regulatory affairs professional for your technical documentation or your formal classification rationale — but it will tell you, quickly and transparently, which rule is likely to apply and why.

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