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Iec 62381 Download Form

Iec 62381 Download Form

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hi this is Rob Packard from medical device Academy and this video is about IEC TIR 8002-1 it's a 2009 guidance document from aami or technical information report explaining how to apply the risk management standard 4971 to software as a medical device and software in a medical device software is a little bit bit different animal on how to apply risk management and Hazard analysis than devices that don't have stuff so it's important to read this particular guidance document for examples on what are hazards and how to go about controlling them what kinds of testing would be appropriate for verification and validation of those risk controls that you've implemented what I see for most companies is we've developed an app great and it works how do we get a get a 510k for this no number one you need to document the software validation of that for that you need IEC 62304 and then one of the documents that's part of that software validation docume

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