S
Hi!
I'm new to this forum and I'm glad to find such a rich information source related to IEC 62366. Since I am software risk manager I am interested in the software aspects of IEC 62366. But the examples in the standard itself are not so related to medical device software, especially regarding documentation and the usability engineering file annex.
Does anybody know where I can get more information about implementing IEC 62366 for Medical device software? After all Usability is very central to software development, so it should be easy to adapt to the process for software. But I haven't seen any examples of that yet. Is it even mandatory to implement a usability engineering process for medical device stand-alone software?
Best regards
Michael
I'm new to this forum and I'm glad to find such a rich information source related to IEC 62366. Since I am software risk manager I am interested in the software aspects of IEC 62366. But the examples in the standard itself are not so related to medical device software, especially regarding documentation and the usability engineering file annex.
Does anybody know where I can get more information about implementing IEC 62366 for Medical device software? After all Usability is very central to software development, so it should be easy to adapt to the process for software. But I haven't seen any examples of that yet. Is it even mandatory to implement a usability engineering process for medical device stand-alone software?
Best regards
Michael