Hello everyone,

Shall we move to next exercise...Please findout the attachement

:topic: There are some people who prefer not to help with what they consider 'student home work'. Usually these people are those who have forgotten what it was like when they started out and knew virtually nothing. Personally, I see no problem in helping someone, including a student. Please keep responses on topic.

Thanks!

The test is okay, but there isn't a huge amount of medical-device-specific stuff in there. That's understandable if the intent is to keep the test generic for students from all backgrounds, and strictly-speaking there aren't that many differences between ISO9001 and ISO13485 anyway.

Risk management and software validation are two key additions, and both are tested.

However a knowledgeable ISO9001 auditor isn't automatically a knowledgeable ISO13485 auditor, so I would have liked to have seen a few more (and punchier) ISO13485-specific questions nonetheless.

Hello everyone,

Shall we move to next exercise...Please findout the attachement

Pick a few that you are struggling with, see if I can help! :)

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Hi! Covers,

THanks for the information.:agree: