I don’t have industry experience yet, but from what I’ve learned, figuring out the critical path seems super important for keeping projects on track. It makes sense that not all tasks are equally urge...

Keeping all the project elements coordinated across the 10 knowledge areas comes down to strong Integration Management, which keeps everything running smoothly. A solid project plan helps align the sc...

Scope management goes hand in hand with time and cost management since all three work together to keep a project on track. The project scope lays out what needs to be done, which directly affects the ...

I think your ranking makes a lot of sense, especially with SOPs being the easiest to change and anything after the design control phase being more complicated. SOPs are mostly procedural, so updating ...

The most common risk in a project really depends on the industry and scope, but schedule risk tends to show up the most. Delays can happen for all sorts of reasons—resource shortages, technical challe...

Scope management goes hand in hand with time and cost management to keep projects on track. A clear scope helps with scheduling by breaking work into manageable tasks using a Work Breakdown Structure ...

I totally agree—regular design reviews are key to catching issues early and avoiding costly delays. One way to make them more effective without slowing things down is by using real-time collaboration ...

In this week's simulation, we were given a failed design verification test and tasked with redesigning the test to find out why it failed and how to fix the test. In the scenario given, there was a si...

Having an in-house regulatory team is really important, especially for companies with a lot of complex combination products. They know the company’s processes inside and out and can handle the mix of ...

Although I don’t have direct experience in managing medical device projects, I can imagine it’s quite a complex process. The combination of strict regulatory requirements, technological innovation, an...

The FDA approves medical devices through two main pathways: PMA for high-risk Class III devices, requiring extensive clinical testing, and 510(k) for moderate-risk Class II devices, which must show si...

Although I don't have direct experience working as a Project Manager, these are some things I have learned through my courses. Conflicts over opinions or work styles can definitely be tricky, but good...

Although I don’t have direct experience managing medical device projects, my background in chemical engineering and biomedical engineering studies have given me insight into the challenges of balancin...

Hi Everyone, I'm currently exploring career opportunities in the medical device industry and am particularly curious about the role of a project manager. I have a background in Chemical Engineering an...

When it comes to agreements, one of the most important things is making sure everyone knows what’s expected from the start. For example, in consulting contracts, being super clear about what needs to ...