One angle I’d add is that in medical device development, credibility with cross-functional teams can matter just as much as credentials on paper. A te...

I like the ideas about SharePoint and dashboards, but I wonder if the format matters less than when the lessons are captured. If teams wait until the ...

I think aligning business needs and customer satisfaction starts with redefining them as interdependent rather than competing priorities. In medical d...

I think the root issue here isn’t just version control software: it’s process discipline. If a design change request isn’t based on the latest revisio...

I think this situation is less about a design flaw and more about the original business assumption being challenged by real data. If the stent dissolv...

I think one aspect that often gets overlooked is how company culture affects the integration of design controls and project management. Even with shar...

I think one commonly overlooked part of creating a strong DHF is treating it as an evolving document instead of something put together at the very end...

One additional factor that strongly influences the medical device product life cycle is post-market surveillance and real-world performance data, whic...

Based on my research, I’d be interested in starting a medical device project focused on a collagen–chitosan hydrogel bandage for treating second-degre...

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 ...