Software in Medical Devices

In my last article, I talked about the most classical methods used to verify software: human testing (driven by test cases or not) and unit tests. I was about to talk about static analysis, that I place at a higher level of complexity in the list of verification methods, but I have to say a bit more about unit tests.

Writing about V&V in two previous posts, I had a lot of comments from people on a well-known social network. They made corrections to my view of V&V and brought their own definitions.
Here is an excerpt of their comments.

Many people make the confusion between verification and validation. There is no exception for software! I'd even say that the confusion is even worse for standalone software.

Let's see first the definition of verification and validation. I borrowed these definitions from the FDA website:

• Verification is confirming that design output meets the design input requirements,
• Validation is ensuring that the device conforms to defined user needs and intended uses.

OK, this remains theoretical. How to do that with software medical devices?
In this article I focus on verification and will focus on validation in the next article: What is software validation.