In my opinion, time, risk, and cost are the three most important knowledge areas in project management. Time is crucial because managing the project s...

I think it would be more effective to use Bottom-Up estimations in most cases. Using analogous estimations can be extremely dangerous for a large, com...

I agree that the top reason that smaller companies may lack a formal QMS is lack of resources.This can also be attributed to budget constraints and a ...

I agree that this would be quite a significant change, particularly because it affects a critical process that could alter the device's biocompatibili...

This topic is explored in Simulation 3, as a problem with cytotoxicity will force a return to the verification phase. This is costly and generally avo...

To build confidence in testing outcomes, teams should proactively engage in interlaboratory comparisons early in development to identify variability a...

Organizations can balance control and flexibility by implementing a structured yet adaptive change management process. This involves clear criteria fo...

Though both are types of verification, scope and design controls verification are quite different. They take place in different project phases and add...

In order to ensure that past project insights lead to real improvements, it is important to continuously track and categorize lessons learned. Trackin...

As mentioned above, collaborations between companies become necessary when one company lacks money, resources, time, or experience to complete a proje...

I think an important motivator for team success is the satisfaction of reaching goals along the way. Thus, a good method for team development during e...

I think it is very important to find the balance between providing enough information to keep stakeholders informed without overwhelming them with exc...

During the initiation phase of medical device project management, key inputs include the Project Charter, feasibility data, market analysis, regulator...

I agree with some of the previous entries that Microsoft Teams can be more efficient than email chains for shorter communication that does not have to...

I think this is a great point because the biomedical industry is highly cross-functional as you've mentioned. To ensure alignment among stakeholders i...