From my experience in the medtech industry, and building off what was said earlier, this distinction actually makes a lot more sense once you see it p...

I did a bit of research, and I agree that the PM’s role shouldn’t stop at market release. One added perspective is that post-market activities often f...

I agree with how most of the responses highlight regulatory, quality, or systems engineering, but I think there’s another angle that’s just as importa...

I like how both responses point out that it’s less about “renewing a license” and more about continuous compliance. Another thing I’d add, from my own...

I’ve seen similar situations too, and I think the biggest shift comes from moving the conversation away from “who’s right” and toward “what’s best for...

The reason these standards cost money is because organizations like ISO and ASTM are non-profit bodies that fund their operations through the sale of ...

I completely agree with your point about the importance of risk management assessments for medical devices. They really are essential for identifying ...

A real life scenario of hazardous material causing significant harm would be in 2004 at the Centers for Disease Control and Prevention (CDC), where a ...

Controlled change really is what keeps product development from turning into chaos. Some common examples of device changes that need to be controlled ...

I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, vali...

I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, vali...

I think our current design control systems are much stronger, but not entirely error-proof. The Therac-25 tragedy definitely pushed the industry towar...

Yes, I do feel safer knowing that validation and verification are applied to medical devices we use today and may rely on in the future. These process...

The best way to translate a qualitative user need into a quantitative design input is to break the need down into measurable characteristics using eng...

Validation and verification are both crucial parts of the medical device development process, but they serve different purposes. Verification ensures ...