I understand the idea of using the DHF as a living document to detail design and development plans and deliverables. However, at my company, once the ...
I found this article that relates to the topic. It digs a little deeper as to WHY it actually takes so long go get devices approved in the US. Accordi...
Another notable difference is with post-market clinical follow-up. For the FDA, PMCF is only required for the highest risk devices. For CE Marking, ho...
There are differences in regulatory approach between the EU and the U.S.. Therefore; there are differences in device classification and we can not ass...
Beyond identifying a combination, I wanted to touch upon some of the challenges that surface when understanding the classification, and jurisdiction o...
I am not very familiar with my companies marketing strategies. However, I do think we use a participation approach. At one of our all employee meeting...
I currently work for a Point of Care medical device company. My company focuses on the hand held type instead of the larger models. Based on my unders...
I think this course was very relevant and valuable. I currently work for a medical device company, so it was cool to see how things I do in practice a...
I work for a medical device company that manufactures blood analyzers. From my understanding of contract agreements, I believe my company would have t...
I have not experienced this but there is an article on NJ. com that really dives into non compete agreements. It talks about the impact of these agree...
Personally, I have found it difficult to work with people I have friendship level relationships at work. We always get things done, but sometime you m...
I think my company operates with a functional organization structure where most of the decisions are made by the managers. There is also little commun...
I read a Forbes article that sought to use a data driven approach to analyze if there are different skills required for senior executives. They asked ...
I work for a medical device company as a manufacturing engineer. It is part of every design change procedure to conduct a Cause and Mitigation Impact ...
I agree that trying to predict extreme events is a critical mistake in risk management. Instead of trying to predict extreme scenarios, I think it wou...