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 is, not just for the sake of organization, but to...

This thread really highlights how broad and serious federal fraud laws are within healthcare. I especially appreciate how several of you broke down the differences between the Anti-Kickback Statue and...

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 action if the agreement is breached. I agree that i...

I agree with the point others made about communication and authority, but I think the impact of organizational structure goes even deeper, it actually shapes how a project team thinks and behaves. In ...

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 assigned by functional areas, none of our delivera...

Working in a matrix organization in the medical device world can feel like The Office: Medical Device Edition, where two managers are giving directions, multiple deadlines that need attention, and mee...

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 interpret it a little differently The FDA focuses heavil...

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 engineers are very close to the design, they tend ...

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 ethical and practical. Sometimes trying to drive risk t...

Design controls under 21 CFR Part 820.30 basically exist to make sure the device is intentionally designed, proven, and documented step-by-step instead of being developed randomly. Each part plays a d...

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 safety. For example, changing a material inside a...

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 gone over how the design begins with user needs but ...

If I were a manager updating design controls, I'd start by improving communication and training before changing any documents or systems. Too often, people see design controls as roadblocks because th...

I think verification and validation can sometimes happen at the same time, especially during prototype testing or early design iterations, but they shouldn't completely merge. Doing both together can ...

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 instead of just relying on what they say. Observation...