Forum Replies Created
RE: Common challenges faced while auditing a Quality Management System (QMS) in the medical device industry & how can they be dealt with 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 changes or complaints back to something they documente... |
4 days ago | |
RE: Most effective ways to manage risk in the context of Quality Assurance for high-risk medical devices (Class III) Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and development. Every change and decision should be rec... |
4 days ago | |
RE: Regulatory Compliance and Quality Assurance 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 simply hardware anymore, they have AI, software u... |
4 days ago | |
RE: How to start career in regulatory area (no industry exp yet) I've also been interested in regulatory affairs since this class started, especially because Professor Simon keeps mentioning how it's a growing field with a lot of job opportunities. What I keep wond... |
1 week ago | |
RE: Who Should Be Responsible for Regulatory Basics? 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, but they need to know the "rules of the game", th... |
1 week ago | |
RE: Balancing Innovation and Safety 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 productive. One challenge I think is about how long t... |
1 week ago | |
RE: Ensuring Biocompatibility in Medical Devices Biocompatibility throughout a device’s whole lifecycle is tough since the body will always react to foreign materials in some way. Even metals like titanium or ceramics can still cause issues over tim... |
In forum Pre-clinical Device Development |
2 weeks ago |
RE: Skills to get into research 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 discovery and publishing. You need to be patient and... |
In forum Pre-clinical Device Development |
2 weeks ago |
RE: Challenges in Applying ISO 10993 Standards I think everyone raised really good points about cost, time, variability in biological responses, and different supplier issues could all be hurdles in device development. Something I would like to ad... |
In forum Pre-clinical Device Development |
2 weeks ago |
RE: Manager Vs Engineering 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 themselves. Even if the manager isn't the more techn... |
In forum Intro to Project Management |
3 weeks ago |
RE: Project Management Strategies in Academia 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 than the industry does. This is definitely the case b... |
In forum Intro to Project Management |
3 weeks ago |
RE: Managing Team Opinions While Sticking to Decisions 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 project team. Since we learned about the importance... |
In forum Intro to Project Management |
3 weeks ago |
RE: Co-Op / Internship Experience I also wonder the same thing if internship and co-op experience gives you a step ahead when it comes to looking for a job. I feel like it's very situationally based because I know of some people who h... |
4 weeks ago | |
RE: Experience vs Education As an undergrad student with no industry experience, my perspective is based off of what I have heard from others. I remember being in a seminar where the professor brought in a past student who is cu... |
4 weeks ago | |
RE: Academia or Industry Preference? @knm7 As an undergrad student pursing a master's degree in biomedical engineering with the hope of working in the industry, I really appreciate this post. From a student perspective, I feel like takin... |
4 weeks ago |