Going private can be a good thing for a company like EA that you mentioned because it gives them more freedom to focus on their long-term goals rather...

I think most people choose an LLC over an LLP because of how much simpler and more flexible it is to manage. My brother actually started his own LLC c...

I was also shocked when the Professor dropped this fact in the lecture video, 80% seemed really high to me for a medical device. I was talking to a cl...

From what I've read, one of the most common issues during QMS audits is weak traceability, especially when companies can't clearly connect design chan...

Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and de...

I think the biggest challenge right now is keeping quality control up to speed with how quickly medical device technology is advancing. Devices aren't...

I've also been interested in regulatory affairs since this class started, especially because Professor Simon keeps mentioning how it's a growing field...

I like how you framed this because it made me think of how it really is all about balance. I agree that engineers don't need to be regulatory experts,...

I think the FDA has a difficult position of wanting to encourage innovation while also making sure the devices are not going to cause harm and are pro...

Biocompatibility throughout a device’s whole lifecycle is tough since the body will always react to foreign materials in some way. Even metals like ti...

One thing I think is interesting when comparing academia and industry is the pace and priorities. In academia, it feels like the goal is more about di...

I think everyone raised really good points about cost, time, variability in biological responses, and different supplier issues could all be hurdles i...

Something I've noticed in my own group projects is how the environment has an impact on whether people actually share concerns or just keep them to th...

I like all the points that have been made so far, it does feel like academia follows a much more relaxed and less structed project management path tha...

I agree with what has already been said and discussed here so far, communication and active listening are vital parts of handling disagreements on a p...