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...

I think having a standardized process for handling adverse events is essential, but it should also include build-in flexibility. Each trial is different, and the severity or nature of an event might r...

I really agree with what a lot of people here have said about the gap between classroom learning and real-world clinical experience. I think spending time in a clinical setting would make a big differ...

I think another interesting angle that hasn't been mentioned yet is how the placebo effect can actually reveal the power of patient-clinician interaction rather than just being seen as an obstacle in ...

To agree with many others, I think the product is overall the most essential part of the four P's. You can have the best promotion, price, and placement, but at the end of the day it's the product tha...

If I were to transition out of engineering, I'd probably lean toward marketing, especially since I'm pursuing a business minor. I think marketing would be a great way to blend the technical knowledge ...

I totally agree that the building trust is the biggest part of being a successful sales rep in the medical device industry. These relationships can last for years, and customers need to know they can ...