Last seen: May 5, 2025
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...
Having a solid plan in place for emergencies is definitely a smart move. If something happened to me, I’d want a clear roadmap for how things should b...
To strike a good balance between protecting sensitive information and being transparent when working with consultants, companies need a thoughtful app...
In manufacturing, risk management is all about catching potential issues early to keep things running smoothly and safely. While avoiding risks is a b...
A key but often overlooked part of risk management in medical devices is human factors engineering (HFE). While frameworks like ISO 14971 help address...
When developing medical devices, figuring out what level of risk is acceptable comes down to balancing patient safety, technology, and costs. It invol...
Managing a big, complex Design History File (DHF) can definitely be tricky, but one good way to handle it is by keeping things organized. Breaking it ...
Design Transfer is a key part of moving from development to manufacturing, and there are a few ways companies can improve it to avoid production issue...