3 days ago
Head of Quality and Regulatory Affairs
Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.
6 days ago
You have a milestone. To achieve it, you need research… so you search. In-house? Crazy talk. Contract Research Organization? Your budget is too small.The University down the road? Now we're talking, you think. They have smart people, cutting-edge equ...
2 weeks ago
Mike Drues is one of the most gifted regulatory people I know. At 10x he said, If you're going to change a medical device in an administrative way, you have two options to handle that. • You notify the FDA (and if you do, how?); or, • You don't notif...
3 weeks ago
If you want an education about human factors, who better than a university professor who is an AAMI chair to teach it? I have the recording, slides, and transcript from MaryBeth Privitera's 10x talk for you today. Human Factors: MB's Main Takeaways U...