Last seen: Mar 2, 2025
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. ...
Keeping all the project elements coordinated across the 10 knowledge areas comes down to strong Integration Management, which keeps everything running...
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 ...
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 com...
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 sor...
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 ...
I totally agree—regular design reviews are key to catching issues early and avoiding costly delays. One way to make them more effective without slowin...
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 f...
Having an in-house regulatory team is really important, especially for companies with a lot of complex combination products. They know the company’s p...
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 reg...
The FDA approves medical devices through two main pathways: PMA for high-risk Class III devices, requiring extensive clinical testing, and 510(k) for ...
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...
Although I don’t have direct experience managing medical device projects, my background in chemical engineering and biomedical engineering studies hav...
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...