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 t...

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 pr...

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 be...

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 a...

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 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 wil...

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...

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 tra...

The most important responsibility of the FDA regarding medical devices is their role in protecting patient safety by ensuring devices are safe for the...