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Which Data Should We Collect In Our Post-Market Surveillance?
Anonymous
updated about 1 year ago
We are an established manufacturer of a class IIb medical device software. Our software is a mobile app intended to analyze a user’s heartbeat, detect abnormalities and inform a physician. The notifie
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Accepted answer
Read my ultimate guidance on PMS and my article about trend analysis. Long Answer Let's start with the regulatory background. I know it’s boring, but
