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...

Outside of a project management role, project management skills can reflect well in leadership experiences and in management of personal goals.Project...

A great way to see the difference in PMA and 510(k) pathways is to answer if the product is life sustaining, and if there is a predicate to the device...

I’m in favor of there being a leader acting as a main head with support. Having support allows for a leader to get quick feedback on goals and plans b...

For medical device classification ambiguity, it is important to understand the intended use of the device and present indications for said use. With t...

A huge factor that can play into preference can be the experience of the individual entering the team. For an individual who is new to the team and le...

For a project manager, handling team conflicts will involve a good amount of proactive action. As mentioned, many conflicts can arise from miscommunic...

With communication breakdowns, it is important to identify potential areas of misunderstanding prior to conveying information. Many breakdowns come fr...

It is incredibly important to predict what risks can come from including new technologies and adapting them within a project. New technologies are cap...

I agree that typically values depend on a case-by-case basis, however in terms of medical devices I believe stakeholder values might take priority. Fo...