With regards to the original post: I think there is a business opportunity for a test lab to offer NRTL marks that basically restrict themselves...
As long as IEC 608025-1 is applied there is no reason to refer to IEC 60601-2-22. For the most part, 601-2-22 has a lot of cross references to...
If the applied part has Uap inside it should have 2 MOPP @ Uap to prevent a path through the patient (or unintended paths in case of stimulators,...
It's probably to late to make a comment, but from a regulatory perspective, there is no "I", rather there is only the medical device. Technically,...
The cliff is derived from a normal probability distribution, which beyond 3-4 standard deviations has a faster fall off than a exponential decay....
Finally before I switch to to watching the cricket ... [ATTACH] The above diagram combines the concept of a fast falling risk with a slowly...
OK, the legal situation is cleared, now let's get to the interesting stuff - the real situation. Many thanks to MarkMeer for challenging things,...
Apologies to Sam, we might have hijacked this conversation, I suspect you were looking for a simple answer to the auditor's question. In that...
Yes and no. The underlying nature of probabilities is the individual risk from most situations literally falls off a cliff beyond a certain point....
I have been developing a broader "risk minimum theory" based risk/resources which relates to this thread. One day I will get around to...
Surprisingly Canada is in effect a requirement, although it is state based, not federal. If the local state laws have adopted the Canadian...
Service life is simply a statement in the risk management file which can be referred to when needed, since it can influence risk based decisions....
Simple answer is no, tools do not need to follow 62304, the just need to be recorded what tools were used. With medical devices it is always good...
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