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 play out- I think of the product life cycle as a ho...

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 function like a series of smaller, iterative projec...

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 important: communication and integration across disciplin...

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 experience in industry, is that project managemen...

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 project.” One effective approach is setting c...

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 their standards. They invest a lot of time and exp...

I completely agree with your point about the importance of risk management assessments for medical devices. They really are essential for identifying and mitigating potential hazards before a product ...

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 serious lab safety breach took place. The hazard i...

Controlled change really is what keeps product development from turning into chaos. Some common examples of device changes that need to be controlled include modifications to the materials used, updat...

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, validation, and verification give a solid technical fr...

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, validation, and verification give a solid technical fr...

I think our current design control systems are much stronger, but not entirely error-proof. The Therac-25 tragedy definitely pushed the industry toward stricter verification, documentation, and risk m...

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 processes make sure not only that a device is built corre...

The best way to translate a qualitative user need into a quantitative design input is to break the need down into measurable characteristics using engineering standards, research, and benchmarking. Fo...

Validation and verification are both crucial parts of the medical device development process, but they serve different purposes. Verification ensures the product meets the specifications outlined in t...