Adding incentives in the contract could be another way to promote both sides to bring out their very best in terms of contract work. Most contracts focus on restrictions that are necessary to protect ...

Like most of the replies here, I agree that having a person who is capable of leading everyone that there is a contracted agreement about what they can and can't do while in charge is what should happ...

Being efficient with disputes between company and contractors is a valid concern, especially since these disputes can interrupt regulatory deadlines, and delay the time it takes for the medical device...

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 between the two. I think this is also similar to Gan...

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 produce has if it fails. Any device that is life-sup...

To meet the value-based care expectations, medical device companies could also focus on creating internal teams that focus on making their medical devices more accessible across more places. This coul...

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...