Question
"You’ve seen these walkers everybody has? Those four-legged walkers? Nobody wants a four-legged walker and that’s what Medicare is going to give you," said Michael Serhan, Executive Principal for Drive Medical, at last year's 10x Medical Device Confe...
When a medical device is being developed, per the FDA, a DMR and a DHR has to be created. The Quality System Regulation call DMR as Device Master Record and DHR as Device History Record. I saw in one set of documentation that the D in both DMR and DH...
This is one of my better posts. You'll want to bookmark and share it. And you'll want to watch http://medgroup.biz/substantial, a 19-minute compilation from 2014's 10x Medical Device Conference. It features Ed Black, Tom KraMer, Pat Kullmann, Doug Li...
We work in a crazy business. Consider the above question, especially with regard to a hospital-used Class III device like a pacemaker, heart valve, coronary stent, etc. Who benefits from the device? The patient. But the patient does not chose the dev...
Group member Mike Tipton sent in this question: I'm working with a start up company. One of our investors asked what are the biggest threats to the medical device space in the short term, and how can you best mitigate that risk? How would you answer?...
Hello everyone, I am looking for standards related to wireless in medical devices. Any advice?Thanks a lotsource: https://www.linkedin.com/groups/78665/78665-6039440149673230339
Sabrina Dessources
Senior Manager Regulatory Affairs-CMC at Alexion Pharmaceuticals, Inc.
August 2015
Good morning everyone, I need some advice please! Hopefully someone can shed some light! The company manufactures IVD devices, and the QMS is currently in conformity with BS EN ISO 13485 (and all other applicable EN ISO Standards). Because we will al...
A group member recently asked, "Where can I find companies with new medical devices or procedures or new products and who want to come to markets in SE Asia, Australia, Europe and Israel. Companies in US or Canada?" How would you advise him? Barry Kr...
Startups are competing to create the next Uber for healthcare. The industry is adapting to the new "sharing economy" and makes use of new technology to provide non-emergency house-call services. Heal, in the LA and Orange County area, promises to get...
I was prepping for a guest lecture on “clinical studies for medical devices” for a graduate-level class on medical technology regulatory affairs. My career has spanned more than 30 years on this topic. I was striving for some learned wisdom beyond ju...
