A
andypatkinson
Hi,
When it comes to verifying our software units that contain a RCM, we use unit tests to evaluate the RCM implementation (is it present and working as expected) and where we cannot test for it (for one resaon or another) we verify by code inspection.
Does anyone see any probem with this?
I have heard from other medical device SW developers ('around town') that because the example in the standard says:
NOTE Examples of acceptance criteria are:
? does the software code implement requirements including RISK CONTROL measures?
That code inspection / review is the only acceptable verification method and that verifying RCMs with unit tests is not 'meeting the intent of the standard'. I have a hard itme accepting that - for me we're verifying that the RCM is present in the unit and I choose to do that by 1st, testing and 2nd, inspection (but only if I have to, i.e. I cannot test for it).
Am I on the money or really going against the 'intent of the standard'?
Thanks in advance......
Andy
When it comes to verifying our software units that contain a RCM, we use unit tests to evaluate the RCM implementation (is it present and working as expected) and where we cannot test for it (for one resaon or another) we verify by code inspection.
Does anyone see any probem with this?
I have heard from other medical device SW developers ('around town') that because the example in the standard says:
NOTE Examples of acceptance criteria are:
? does the software code implement requirements including RISK CONTROL measures?
That code inspection / review is the only acceptable verification method and that verifying RCMs with unit tests is not 'meeting the intent of the standard'. I have a hard itme accepting that - for me we're verifying that the RCM is present in the unit and I choose to do that by 1st, testing and 2nd, inspection (but only if I have to, i.e. I cannot test for it).
Am I on the money or really going against the 'intent of the standard'?
Thanks in advance......
Andy