Within the medical device industry, the FDA device review is the process in which FDA review teams review submitted data to determine whether to appr...

While external hiring can diversify staff, bring new skills to the team, and create a larger talent pool, internal hiring has a large amount of benefi...

While I have not managed projects myself within academics or medical device development, in terms of improper estimation of costs I have also seen an ...

I do not have much industry experience either in addressing project planning, however in what projects I have seen and participated in there have been...

This is an amazing definition of the concept of project initiation. Keeping in mind all the objectives of project initiation, I’m curious about what c...

Hello everyone! My name is Olena and I am a BME Undergraduate student at NJIT. Here is my LinkedIn, looking forward to connecting with you all!

This is a great definition of task scheduling! Another couple of details to include is that task scheduling can change throughout the project based on...

Emails are best for more formal communications and messages that are meant to be sent to a large number of individuals. In case multiple emails build ...

A great way to keep up with regulatory changes is via predicting what changes can occur. Some organizations undergo analysis of past regulatory change...

@sarahqudah1 I believe that with medical device projects, market adoption is one of the more overlooked issues. Cost and accessibility of the product ...

Especially in terms of medical device development, early start and finish dates allow for flexibility in schedule that can be incredibly helpful based...

While all these risks are incredibly significant, one that is constantly present from the beginning of a project is financial risk. Questions on the p...

One thing to consider with the testing of worst-case scenarios is the resources that get used within this verification process. Worst-case scenarios c...

One of our largest issues for the project simulation involved having a clear line of communication. The presence of a discussion board in both the gro...

Something that stood out in the process of designing the bottle labels was how it failed criteria at the 37C bath test. Likely what occurred was the a...