Last seen: Nov 28, 2025
I agree with the idea that having a clear and legally documented plan is crucial for any company's stability. A lot of you emphasized how important it...
This thread really highlights how broad and serious federal fraud laws are within healthcare. I especially appreciate how several of you broke down th...
Nick, you brought up an important point about NDAs serving a dual purpose, not just protecting the company's IP, but also creating a clear basis for a...
I agree with the point others made about communication and authority, but I think the impact of organizational structure goes even deeper, it actually...
After working in our groups for a couple of weeks, I think a matrix organization makes the most sense for our device development. Even though we were ...
Working in a matrix organization in the medical device world can feel like The Office: Medical Device Edition, where two managers are giving direction...
One often overlooked part of global risk management is that even though the U.S., Canada, Australia, and Japan all endorse ISO 14971, they each interp...
It's not idea when the project team also handles risk management in cases where the device introduces new technology or unfamiliar clinical use. When ...
I agree zero-risk devices aren't realistic, but I think the bigger issue is that "acceptable risk" isn't only an engineering decision, it's also ethic...
Design controls under 21 CFR Part 820.30 basically exist to make sure the device is intentionally designed, proven, and documented step-by-step instea...
Some examples of device changes that must be controlled include any change that can alter how the device performs, interacts with the user, or impacts...
I think the best way to balance user needs with business limits is to acknowledge that both sides are part of the design problem. In class, we have go...
If I were a manager updating design controls, I'd start by improving communication and training before changing any documents or systems. Too often, p...
I think verification and validation can sometimes happen at the same time, especially during prototype testing or early design iterations, but they sh...
I agree that vague feedback can be hard to use, but I think teams can still learn a lot by watching how customers actually interact with a product ins...