My favorite way to work is by projects so a project based organization would be awesome. I enjoy the drive and pressure that comes with doing a project. However, this does not seem to be a long term s...

A project manager can be skillful about aligning business needs and customer satisfaction by doing many things. The project manager needs to be able to define the project scope so business goals can t...

FDA reevaluation depends on the type and impact of the change to the product. Not all upgrades require a full FDA review, but some upgrades do. Basically, if a change could affect safety or its intend...

I agree with many of my classmates' responses that a DHF should be treated like a living document. It is not something that should be done at the end of the project but something fabricated as the pro...

I would prefer to work under a project manager that primarily communicates in person as I like that connection, and it makes me feel more involved in whatever project is being worked on. Having an onl...

A product life cycle, from my understanding, describes the lifespan of a product from its creation until its retirement and is driven by business and operational needs while a project life cycle descr...

I prefer to have a small team as the project feels a lot more personable to me. With a large team, while I am a lot more focused on a certain area, my heart is not in the project as much as it is with...

After doing some additional research tied with this question, I believe that I can provide some additional information from jal58's response. The FDA does not issue renewable licenses for medical devi...

I believe that a good project manager needs a lot of exposure to industry so they should have extensive work experience in research & development or systems engineering. However, I'm going to focu...

In my opinion, a project manager in the biomedical field does not need to have a lot of technical expertise. Instead, they must have a good set of interpersonal skills and be able to read and extract ...