I think effective risk responses are the ones that are realistic and proportional to the actual risk, not just theoretical solutions pulled from a lis...

I think my personal experience adds some real insight here. I’ve met a lot of PMs in the medical device field, and most of them started with degrees i...

One of the main goals of a project manager is to deliver a successful project on time. Since teams are made up of different personalities, conflict is...

Project managers can manage their inbox efficiently by organizing emails into folders based on projects or teams. These folders group related emails t...

I understand the point that missing a milestone can sometimes lead to a better or more successful project, but I do not fully agree. Milestones are es...

Hello everyone, My name is Anthony D'Alessio, I attend NJIT where I am a master's student in the mechanical engineering department. I look forward ...

Biomedical projects are especially challenging because project managers must balance strict timelines, FDA regulatory requirements, budgets, and coord...

I think the answer to this question is actually very simple. At the end of the day, a company is a business, and the goal of any business is to maximi...

I agree with many individuals in this forum where a hands off approached is better than a micro manager. A hands off leader allows the members to mana...

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...