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 product has been transferred, the DHF is sealed an...

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. According to the article, Innovative medical devices take...

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, however, all product families are required to have e...

There are differences in regulatory approach between the EU and the U.S.. Therefore; there are differences in device classification and we can not assume that meeting the requirements for the U.S. mar...

Beyond identifying a combination, I wanted to touch upon some of the challenges that surface when understanding the classification, and jurisdiction of these products. Common challenges include legal ...

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 meetings last year a representative from the ER departmen...

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 understanding of the market, PoCT is slow to launch new ...

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 aligns with regulation and applies to general conce...

I work for a medical device company that manufactures blood analyzers. From my understanding of contract agreements, I believe my company would have to have contracts with Singapore as they are the ma...

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 agreements on people who are seeking to switch jobs. “O...

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 may need to critique someone’s work or push back on...

I think my company operates with a functional organization structure where most of the decisions are made by the managers. There is also little communication between silos within my own department. We...

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 332,860 bosses, peers and subordinates to indicate...

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 Assessment where we evaluate the risks associated ...

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 would be better to focus on the consequences. Instead...