A
Aaria
Hi, I read few of your threads related to IEC 62304. I would be glad if you can help initiate a discussion which would be related to the 'cons'/flaws in 62304. Is the fact of the confusion to determine the safety classification of the software, and the amount of documentation that follows, is unnerving for manufacturers? Not to forget this standard being integrated in the 60601-1 3ed. I am still naive about this standard, but any such key points from you to discuss would be very helpful.
Thanks for your help in advance.
Thanks for your help in advance.