Hi,
I have many questions, sorry...
I was told that even though we use agile software development method, we should write the software and product development plans and SOPs as the Waterfall method were used? Is it so?
I wonder this, because I am used to make Quality Management Systems and in those the idea is to describe the process how you actually work - is it true that now according to the ICE 62304 we should describe Product Development Process once again for the notified bodies?
(We develop cloud based software, which is also the product. All development work we make are actually changes to the originally product. They are managed as an agile process. As soon as the feature is coded the ticket is marked "ready for review". The other person review the code, make unit tests and automatic regression test. If there is no problem, they mark is approved. Just thinking, is it really needed a separate Verification document...?)
I have many questions, sorry...
I was told that even though we use agile software development method, we should write the software and product development plans and SOPs as the Waterfall method were used? Is it so?
I wonder this, because I am used to make Quality Management Systems and in those the idea is to describe the process how you actually work - is it true that now according to the ICE 62304 we should describe Product Development Process once again for the notified bodies?
(We develop cloud based software, which is also the product. All development work we make are actually changes to the originally product. They are managed as an agile process. As soon as the feature is coded the ticket is marked "ready for review". The other person review the code, make unit tests and automatic regression test. If there is no problem, they mark is approved. Just thinking, is it really needed a separate Verification document...?)