I would generally disagree with restricting what a private company (independent of the government) could charge for its products. It is the companies ...

I believe your average engineer does not need to worry about a company being either public or private in their work. In theory, much of the work at bo...

In short, yes. Starting in 1886 with Santa Clara County v. Southern Pacific Rail Road and about a half dozen United States Supreme Court decisions ove...

I can see myself working in the QA/QC process. I think the requirements for such a role should not be that stringent. Often times biomedical engineers...

Without a doubt QA/QC is the most important aspect of the medical device development process. Of course, there would be no quality control if there is...

I would believe the first step is to have a centralized system for all control documents. As a company grows, some divisions update their internal pro...

As some have said before me, I don't believe we should "speed up" the approval process. I am sure there are areas which can be done more efficiently a...

Precision and accuracy are essentially different ways of saying effective and safe. When something is precise you achieve a more predictable result. I...

I feel in principle the 510k approval process makes a lot of sense. If you want to improve upon an existing device that has already shown to be safe a...

I don't believe it is unethical to test on animals. With that said, the testing being performed on animals must be fully thought out and made with goo...

I would prefer my research to have a direct impact in my lifetime, more so to "see the fruits of my labor". However, I believe more often than not any...

I believe it would incredibly dangerous to cut corners in research and then use poor results to then sell a product. It is counter-intuitive to compri...

I believe that the transition to a virtual environment has improved project communication. While some aspects of virtual work have existed prior to CO...

I believe one of the best ways to estimate task duration is to find a similar project that accomplished the same goal to understand that if the condit...

Challenges in project management for medical devices would be the rules outlined by regulatory bodies. Many people have mentioned that the FDA imposes...