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, there are methods to better quantify the risks involv...

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 risk involved in a project will determine the need...

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 the product components. The listed specifications ...

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 (DSD). This is where the meat of the engineering is...

This question becomes tricky because these documents should be carefully reviewed to ensure the safety and effectiveness of the device. We would not want minor miscalculation to snowball into a much l...

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 are familiar with the process. The most important ...

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 Class II devices will require a investigational dev...

While the enforcement of regulatory compliance maintains safety and effectiveness of medical devices, it stymies innovation in the medical marketplace. As ec52 discussed, the EU's transition to implem...

I am not currently working in industry, but a variant of matrix organization structure would provide a suitable working environment. Consider an organization that separates their company into differen...

The funding of a project is dependent on the corporate strategy. If a medical device corporation aims to improves preventative healthcare, the company will take on projects that align with prevent dis...

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 the relationships you foster. Your relationships def...