Validation & Verification are never a lost art
One of my favorite sources for Technical Data specifically related to Quality is Master Control. They are prolific but their stuff is always good, very timely, and applicable to anyone in the Device world.
Lately, I’ve been hearing a lot about the two V’s, Validation and Verification, and if I’m hearing a lot about it as a recruiter it means that FDA has turned the heat up on the world of device-making. I almost want to say, ‘it’s funny …’ but the thing is, it isn’t funny. Nothing that might put a patient at risk is ever funny.
V&V is easily overlooked, often taken for granted and frequently undervalued. Too often we take for granted that our knowledge of the FDA’s need is equal to or greater than theirs. After all, we’ve spent untold hours researching this stuff, understanding what the predicate devices are and justifying our product, nay our very existence, on the 510(k) we believe the predicates justify.
But what do we do when FDA comes back to us and says, “Sorry”? In our shop, we have heard from an above average number of clients that this word is being used more often than they’d like to hear it.
So, here’s a link to an excellent understanding of V&V as it applies to a First in Human Study; but I’m pretty sure the information is transferrable to other areas of your business.
What Verification and Validation Activities are Required for a First in Human Study?
Don’t get trapped in that omniscient mindset where you keep reassuring yourself that you are right and ‘they’ are wrong. There is too much help out there from too many potential sources. Use it!