Ignoring skills that are specific to the industry, I think the most important skill a project manager needs to be able to do is communicate. Regardless of which industry, their job requires them to co...

In some ways I would say that the skills required for project management are transferable. Overseeing other roles, organizing such, communicating, and just generally ensuring that the project proceeds...

While I do think that, in theory, a global regulatory system would be great, I think in practice it would actually be less effective than having multiple regulatory systems. Look at the FDA, there are...

I think that it is a reasonable investment solely because without technical knowledge you cannot be an engineer. That is the basis on which you go to school; i.e while there are many other scenarios i...

Although I am not a project manager, I do actively work in a lab and with a team. I've found that COVID did disrupt the flow of conversation and information early on, but by implementing required zoom...

I agree with many of the ideas above stating that a log should be created and so on, but I also think that the project manager should incorporate discussing mistakes, failures, and how those failures ...

An NDA can prevent people from talking about the concept but it doesn't give you a legal claim over the project or concept. A patent would allow you to not only claim rights to the product but to sue ...

So funny enough my father is a physician and I have actually seen him uncomfortably try and manage around companies or people who don't entirely respect these restrictions. I think that these restrict...

The main difference between the two is, as said in many of the responses above, documentation and defendability in court. An oral or verbal agreement is spoken, but unless there is further documentati...

Another benefit of Post-market surveillance is that it protects patients. While it may save the company money and help the company make easy improvements to their devices as necessary, ultimately Post...

Another factor to consider is the Duration of harmful events. For example, cancer therapies and surgeries often cause adverse symptoms in patients that can last for the entirety of their treatment and...

In medical devices specifically, I would think that the nature of how a device may fail and harm an individual and the extent of the harm would impact and contribute to the risk value. While the likel...

I think a balance of both individuals with whom you have a relationship and individuals who have the required skill-sets/knowledge base makes for a good project team. A team made entirely of your, "fr...

In all honesty, I think that the traits of upper and middle management are quite similar (depending on how you look at them). Both are required to be able to communicate effectively, articulate plans ...

From my limited experience, I think I would actually prefer working in a project-based organization. While a matrix-organization does allow for potentially more personal growth since I would be workin...