Last seen: Dec 4, 2022
To bounce off of the ideas from the poster above me, the fact that the FDA is only managing the drug/device development process within a single countr...
I think that the EUA is a great way to push forward critical use medical devices and applications to the general public in times of dire crisis and em...
One common device that comes to mind where stability is extremely important would be a stent. A stent is like a type of scaffold that is designed to h...
For me, I would like to feel confident that the project is going to see completion. This aligns with many of the points that previous posters have alr...
I am currently working in industry and I love the fast-paced environment and pressure. It almost feels like I've grown up in this environment and it's...
It's definitely trickier because outside countries have much different regulations than the US or wherever the medical device originates from. There m...
It can be said that it is an ultimate goal for most people to end up in a managerial position (perhaps even a director or even higher), while I have h...
It's always important to look back at any lessons learned document because as you said, knowledge transfer is key. I've seen too many times where a ne...
I agree with @anthonynjit above - sometimes budget is not there for smaller projects therefore there is less QA/QC support on that end. A company need...
Recently I've taken on a role as a production scheduler at my company, so in terms of being a "leader" for one of the management sectors I've taken on...
My decision in the mini-sim was to go with only one other vendor. The ask was for at least one other vendor to source the coating from for the project...
I think I would ask my team where we think the roadblock is coming from and see what I can do to help the situation. Problem solving sometimes is best...
While I understand companies wanting to rush timelines and get their products out to market and - as @mmd55 said above - especially in medical devices...
Personally I don't think reprimanding or punishing the employee is the correct way to go about it, I think there should be a meeting to discuss how to...
I think in terms of "success" we want to consider all projects as successful whether they were seen to full completion or not. Ultimately, a project s...