T
Talichek
Hi all.
I'm new to MDD and still learning. Need to confirm some of my thoughts.
I need to make test reports according iec 62304 & 62366
i have 2 questions about it
1. IEC 62304:2006/AMD1:2015 May i apply the test report according the 2008 edition?
2. IEC 62366-1:2015 as much as i understand it's basically the same as the first edition with the change of the second part of the standard as approved by FDA as 62366-2, or the standard itself comes with changes that effect on the test report?
on both cases my game plan is rely on earlier editions as a base of my work, as no changes was made on the devices, so accordingly, my presumption is that the test reports don't have to change a lot or even at all as the amendments on both of the standards unrelated to them directly
Gladly will get some thoughts or guidance form more experienced users))
I'm new to MDD and still learning. Need to confirm some of my thoughts.
I need to make test reports according iec 62304 & 62366
i have 2 questions about it
1. IEC 62304:2006/AMD1:2015 May i apply the test report according the 2008 edition?
2. IEC 62366-1:2015 as much as i understand it's basically the same as the first edition with the change of the second part of the standard as approved by FDA as 62366-2, or the standard itself comes with changes that effect on the test report?
on both cases my game plan is rely on earlier editions as a base of my work, as no changes was made on the devices, so accordingly, my presumption is that the test reports don't have to change a lot or even at all as the amendments on both of the standards unrelated to them directly
Gladly will get some thoughts or guidance form more experienced users))
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