List of Contributions

Dear colleagues At the end of each month, I compile a summary of FDA approvals, warning letters and recalls from the prior month. Let me know if you find this information useful. Click on the image below for details Medical Device News | De Novos, PMAs, 510Ks, Recalls, Warning Letters ...

Dear Colleagues: If you are interested in learning about benefit-risk for AI/ML devices, I want to invite you to join my Let's Talk Risk! discussion on LinkedIn next week. It is a very casual and informal discussion about risk-related topics. It is not a webinar or a lecture. I will be ...

Dear colleagues It is not uncommon in our medical device industry to work through an environment where our organization has received a warning letter or we are managing a recall. I wonder if this has any impact, perhaps unintended, on the risk management process. Recently, I posed this ...

Dear colleagues Risk management is a difficult topic in practice. That is why, sometimes it is good to learn from others in a totally different industry. In this post, I would like to share a recording of a recent Let's Talk Risk! conversation I had with a colleague from the auto industry ...

Dear colleagues - I would love to hear your opinion on this question. In practical terms, should we treat both Severity (S) and Probability (POH) to have the same impact on risk or is one more impactful than the other? Recently, I did a quick poll on LinkedIn which prompted a good discussion. ...