Many times in the weekly lesson, we learn about two ways to run a part of a company or project, and we often learn that most versatile is a balance be...

Besides the type of project determining what type of matrix is used, another factor that should determine the matrix used is the amount of risk the pr...

To meet the value-based care expectations, medical device companies could also focus on creating internal teams that focus on making their medical dev...

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 ...

I think the distinction is important because they happen at different stages, and thus must be managed differently. Hazards are managed by prevention ...

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 op...

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,...

A good CM manufacturer should validate machines and have a maintenance plan, and also provide full documentation for proof that the process works the ...

I agree that multiple review meeting should be made during a medical device's lifecycle. Deciding on how many meetings are happening should be governe...

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 str...

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 o...

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 immediatel...

An important guideline for medical companies is ensuring data integrity in clinical research. This is where the ALCOA+ principle (Attributable, Legibl...

Along with everything else, everyone has mentioned, biomedical engineers also help with making sure that what a clinical trial measures actually matte...

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...