Question
Hello all,Do you know if the FDA can inspect your emails if you used email as a record as a proof of compliance?Thankssource: https://www.linkedin.com/groups/2070960/2070960-6326393967122489345
This week I'm inviting group comments about medical devices intended to reduce pain without drugs, and your experience with these devices if you suffer. Recent CDC statistics: As many as 1 in 4 on prescription opioids struggle with addiction. 64,000 ...
I'm very excited about this one, a free webinar from Elizabeth Brooks entitled "How to Get Past the Value Analysis Committee" at https://medgroup.biz/VAC. I was with a client with great technology and minimal sales. The doctor/co-founder was lamentin...
I had the opportunity to speak with Terry Sweeney of Philips Healthcare about the upcoming changes in the Medical Device User Agreement. With MDUFA going up in 2018, this information is essential to anyone in the medical device community. Terry Sween...
Group member Roger Cepeda wrote an informative (and cleverly worded) piece at https://medgroup.biz/RWE called "FDA’s Guidance on Real-World Evidence for Medical Devices: Great for Class III Registry Participants, But What About the Rest of MedTech?" ...
If you're doing business in Europe, I recommend you download this free report from ICON plc at https://medgroup.biz/ICON-MDR There's way too much for me to summarize in the space LinkedIn allows. Here are my oversimplified observations. • European ap...
This week, you and I will write the global announcement together. I'm inviting each of you to leave one comment that shares an insight you have about running a successful medical device business. Whether your expertise lies in design, development, ma...
The release of the FY 2018 FDA user fee schedule was delayed until the end of August, because the re-authorization of user fees was not approved until August 18, 2017. For PMA submissions and related supplements there is a 33% increase. For 510(k) su...
"If you're developing a device and it doesn't integrate some kind of intelligence, you are contributing to the problem," began Spyro Mousses PhD at his 10x Medical Device Conference talk in May. His nine-minute talk and slides at https://medgroup.biz...
At the 10x Medical Device Conference, Francisco Miguel Trigueiros, Managing Director of Global Product Marketing, gave us this analogy. Sliced bread was invented by Otto Rohwedder in 1912 but he sold zero units in 15 years. It was Wonder Bread that m...
