I think documentation of each potential risk found and measures to deal with it, whether it be avoidance or mitigation. It's important that if a risk it found, there's no way for it to appear frequent...

I think the distinction is important because they happen at different stages, and thus must be managed differently. Hazards are managed by prevention to stop the danger from ever happening in the firs...

I think a good way to decided what levels of residual risk is acceptable is to create a quantifiable way to measure it, instead of leaving it up to opinions. The scale would make it clearer for how of...

The failure of the DePuy hip implant is probably due to not enough diversity in the testing population. Real world patients can vary widely in weight, height bone density and levels of physical activi...

A good CM manufacturer should validate machines and have a maintenance plan, and also provide full documentation for proof that the process works the same way every time. The document should have test...

I agree that multiple review meeting should be made during a medical device's lifecycle. Deciding on how many meetings are happening should be governed by what goals must be met before being able to m...

I would probably say that this is more a case by case approach. For devices or features that are high risk, verifications and validation should be strictly separate to keep results trustworthy. But fo...

How about instead you design the DHF around making it easier for the reviewer to read it in mind, rather than the regular documents? Starting with a one-page index of the most critical user needs and ...

Design control can actually be better for innovation, as it acts as a filter that would let ideas that wouldn't pass regulation be rejected immediately, and the constraints would force for more unique...

An important guideline for medical companies is ensuring data integrity in clinical research. This is where the ALCOA+ principle (Attributable, Legible, Contemporaneous, Original, Accurate, plus Compl...

Along with everything else, everyone has mentioned, biomedical engineers also help with making sure that what a clinical trial measures actually matters. The study has to show specific results that sh...

While GCP regulations can slow development, the FDA has several programs in place that see to expedite the wait time. In class when learning about the specific pathways that medical products can take,...

You can make medical device marketing more ethical and accurate by doing a human-factors testing, something similar to testing that's done during device design. Before releasing ads about the product ...

I think one way to keep medical device marketing effective while still being ethical is implementing something similar to a traceability matrix into the marketing process. This would require every sta...

For marketing products in general, knowing who your audience is can determine how to optimize your marketing strategy towards that audience. For medical devices specifically, that audience would typic...