Software validation vs design V&V?

[Watchcat]

I'm trying to tease out the difference between software validation and design V&V, when the medical device is a SaMD. Any insights?

- Once you validate the software, what is left to do for design V&V?
- Is validation of the software part of design verification? Design validation? Neither one?

 

[chris1price]

I would say software validation is equivalent to Design Verification, ie ensuring the correct code has been written. However you still need Design Validation, so Human Factors studies and making sure the code does what was intended in the first place.

 

[yodon]

Unfortunately, guidance docs, etc. do a pretty poor job of describing expectations for "software validation" and, frankly, 62304 doesn't help since they introduce even a 3rd term, "software system testing" (and explicitly excludes validation). As @chris1price points out, you'll still confirm requirements are met; i.e., verification and still have to do (system) validation. Some software requirements are often necessary to test at a lower level (debug versions).

FDA has a Guidance doc on software validation which is probably your best resource. If you read it, you'll see they consider software validation more than testing, it's more of a well-defined software lifecycle (processes) that covers the life of the system.

 

[somashekar]

IEC 62304
Look for more here

 

[Watchcat]

IEC 62304

Thanks. I haven't looked at IEC 62304 recently. I was thinking it was strictly about the software. Didn't realized it took a device-level view.

 

[Watchcat]

I would say software validation is equivalent to Design Verification

I've always said that, but to medical device people. When you are dealing with a startup that involves only software people, no experience with medical devices...I have found it challenging to explain.

 

[Watchcat]

they consider software validation more than testing, it's more of a well-defined software lifecycle (processes) that covers the life of the system.

Yes, more familiar with the guidance. But I don't think it addresses the difference between software validation and design validation for a medical device. Possibly a consequence of the mutually agreed upon fantasy that software stands alone.

On the other hand, I did have a breakthrough on that part, explaining to a software guru that all software is ultimately "embedded," including SaMDs, and he seemed to agree.

 

[Ed Panek]

Do you have any past audit reports for this device from a regulatory authority and how those parts were submitted/responded to?

 

[Watchcat]

Nope, it's a startup getting ready for their first submission to FDA. They at least seem to have some professional software developers, but not with medical device experience.

Beyond that, I already have another similar startup, so I'd like to come up with a way to not only explain this to them, and also to figure out how I go about answering my first question...first and foremost, to my own satisfaction.

- Once you validate the software, what is left to do for design V&V?

I think the digital tsnunami may have finally arrived. I was really hoping to retire before that happened, sigh.

 

[Tidge]

I would say software validation is equivalent to Design Verification, ie ensuring the correct code has been written. However you still need Design Validation, so Human Factors studies and making sure the code does what was intended in the first place.

I don't disagree with the second sentence, but I think the first treads on dangerous ground. I wouldn't say that part out loud or write it down.