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How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage

The Medical Devices Group provides Medical Device Academy creator Robert Packard. In an hour-and-a-half workshop, Rob covered Changes to RTA procedure, Human Factors Guidance, Changes to eCopy procedure, Small Business Qualification Changes, Interoperability Guidance, eSubmitter software program condition, Device Modification Guidances, Quik 510(k) Pilot, Impact of De Novo & Fee Changes, Cybersecurity Policies, UDI Requirements, New ISO 10993-1:2018 Standard. for the slides.