As you have mentioned, there are three classes of medical devices, Class I, II, and III. Class I devices are those with the lowest risk and they are typically exempt from premarket review. Class II de...

I have had some experience working with teams for a project. In my personal opinion, I believe that smaller teams tend to work better to accomplish projects effectively. Obviously, there is a time and...

Like many others in this forum, I believe that knowing the basics of project management is critical for one's career even if they are not trying to become a PM specifically. As a mechanical engineer, ...

The main difference between PMA and 510(k) pathways is the level of risk and market evidence required. For class II devices 510(k) is typically used and it allows manufacturers to demonstrate the equi...

When a team member has more expertise than a PM and a conflict arises, the project manager should utilize that expertise rather than compete with it. A lot of the times PM do not want to hurt their eg...

A project manager’s main goal is to lead their team and fulfill all the required deliverables for the project. Obviously in any team setting there will always be some sort of conflict to arise. The pr...

While there are pros and cons to both online and in person, I believe that in person PMs are a much more effective option. After dealing with numerous online interactions post pandemic, it is obvious ...

I think in any capacity of the world, people are taught to be leaders, and no one is truly a "born leader." While many individuals may have better traits to become a leader than others, I do not think...

The most important responsibility of the FDA regarding medical devices is their role in protecting patient safety by ensuring devices are safe for their intended use. One of the reasons that this is s...