Question
source: https://www.linkedin.com/groups/2070960/2070960-6060571923853701124
Dear all, Does EU call out a specific amount of years an electromechanical medical device is required to last in its lifetime?Any comments or links to information would be greatly appreciated.Kind regards,Tomsource: https://www.linkedin.com/groups/20...
There’s a catchphrase on “The West Wing” television show that captures our experience building a community on LinkedIn. “I serve at the pleasure of the President.” In a similar fashion I, Joe Hage, serve at the pleasure of LinkedIn. If I play in thei...
Photo credit: Dule Hill on WhoSayThere's a catchphrase on "The West Wing" television show that captures our experience building a community on LinkedIn. "I serve at the pleasure of the President." In a similar fashion I, Joe Hage, serve at the pleas...
Hi everyone, I am looking to learn more about the US medical device landscape. I am looking to learn where most medium-sized medical device companies are located, what major medical device magazines and websites I should know about and how you recrui...
If you have a moderate risk device you probably will submit a 510(k) before applying for CE Marking, because some of the requirements for a technical file are more challenging than European requirements.Risk Management FileThe FDA only requires docum...
source: https://www.linkedin.com/groups/78665/78665-6057576640882495490
Tim Hopper, MBA
Helping Medical Device/Drug Delivery Companies Accelerate Commercialization Timelines | Bringing Napkin Sketches to Life
October 2015
The boundaries between the traditional drug and medtech realms are gradually eroding, being redrawn, and then eroding again.Blurred Lines: Big Pharma's On-Again Off-Again Relationship with Medtech | QmedThe boundaries between the traditional drug and...
I'm using this week's announcement to build on a post from my friend Sailesh Chutani, CEO of Mobisante. Shortened for brevity, he writes, "The premise of wearables is if folks could instrument themselves with appropriate sensors and become aware of l...
Hello everyone,For one of my design classes for medical devices we have to go through all forms of an FDA submission. One of the requirements was design inputs and outputs, I was curious is there a certain format that this should be written in and ho...
