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Hello Anonymous, It is hard to respond without knowing more. What standard was initially used to create the device? How was the device initially validated? Cadaver, report from Engineer? Why is the change being made? Has a risk analysis been performed to assess the risks associated with the ...

Thanks Ella. Interesting. We have standalone software for which 82304 applies, however we used 62304 because it was on the list of harmonized standards for MDD and we knew auditors would be familiar with it. No one asked for 82304. Good luck! Jean ------------------------------ Jean Bigoney ...

Hi Ella I am curious who is asking for the 82304 standard, as it is not on the list of any EU harmonized standards (yet). Are you able to share that information? ------------------------------ Jean Bigoney PhD, RAC, CQE Senior Regulatory Affairs Specialist Morrisville NC United States -- ...

Hi Anirban Can you clarify which jurisdiction? And is this for devices or drugs? Is this US only? For example, for the US, nothing will change as far as how devices were cleared. That is something that happened in the past. All documents that contain the address of the manufacturer will have ...

My understanding is that if you are testing performance of a medical device, ISO 14155 is the appropriate standard, and if you are testing an IVD, ISO 20916 is the appropriate standard. FDA recognizes ISO 14155 but not ISO 20916. This doesn't mean you can't use ISO 20916 for an FDA submission, it ...