Within the medical device industry, the FDA device review is the process in which FDA review teams review submitted data to determine whether to approve the device or not. In this process, there migh...

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 benefits that make it more beneficial to project manager...

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 extension within the project time-line. If the bud...

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 common factors. Before the initiation of any work...

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 complications can arise within the medical device i...

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 the schedule available, risks, technical specific...

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 up, it is a good idea to re-evaluate what older em...

A great way to keep up with regulatory changes is via predicting what changes can occur. Some organizations undergo analysis of past regulatory changes in order to understand how regulation can develo...

@sarahqudah1 I believe that with medical device projects, market adoption is one of the more overlooked issues. Cost and accessibility of the product are important to consider in the creation of it. H...

Especially in terms of medical device development, early start and finish dates allow for flexibility in schedule that can be incredibly helpful based on issues occurring with the project. Issues with...

While all these risks are incredibly significant, one that is constantly present from the beginning of a project is financial risk. Questions on the presence of the finances needed for resources, work...

One thing to consider with the testing of worst-case scenarios is the resources that get used within this verification process. Worst-case scenarios can involve a multitude of possibilities without sp...

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 group canvas and main course assignment canvas was a ...

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 adhesive degraded in some form with response to hea...