Evaluating risk may not be as murky as it may first appear. The lectures does not go too deep into risk management, but after assessing the risks, the...

The team structuring of risk management is dependent on the risk, resources, and time restraints on the project. As mentioned by jb678, the amount of...

In resolving failure, the first step to take is to define the scope of what can be modified. In our simulation, this is the verification protocol and ...

If I was placed in the Design Control process of a project, I would likely find preference in the putting together the Design Specification Document (...

This question becomes tricky because these documents should be carefully reviewed to ensure the safety and effectiveness of the device. We would not w...

From my experience working on projects, deciding on detailed specifications may seem to be the most daunting task, but becomes clear-cut the more you ...

As Dr. Simon discussed in his lecture videos, the clearance of a Class II device can at times be as costly and timely as a Class III device. Certain C...

While the enforcement of regulatory compliance maintains safety and effectiveness of medical devices, it stymies innovation in the medical marketplace...

I am not currently working in industry, but a variant of matrix organization structure would provide a suitable working environment. Consider an organ...

The funding of a project is dependent on the corporate strategy. If a medical device corporation aims to improves preventative healthcare, the company...

I believe that the 70/30 for success is completely justified. If anything, 70% interpersonal skills is too low. The most important thing in life is th...