Hi Guys!
Our NB (SGS) recommended as per "shall"
to include the IEC 62304 classification of the software running on/in our instruments into the release test reports. I have never heard about it that the Verification/Release Test Report shall contain a statement that the software is Class B (In our case the software is Class B according to IEC 62304). The IEC 62304 regulates the entire SW development cycle why the SW test report shall contain this information only?
I have googled here on elsmar but no found any related topic. Have anybody heard about this "issue"?
Thanks in advance,
Attila
Our NB (SGS) recommended as per "shall"

I have googled here on elsmar but no found any related topic. Have anybody heard about this "issue"?
Thanks in advance,
Attila