Question
At Qmed/MPMN, we've noticed that stories about serious recalls garner a lot of Web traffic from our device designer and engineer subscribers. Maybe it is the same type of psychology that causes people to run down the street to check out a burning hou...
Hi all. If my EC representative is presently based in the UK, do I have to change him? If so, by what date?What is the BREXIT on non-EU manufacturers with UK-based representation?
Group member Amy Baxter, MD, is furious. "I just got back from #PAINWeek where supposedly doctors are learning about what works for their patients to manage pain. We brought our new DuoTherm low back pain thermal/vibration prototypes – almost all the...
One issue I always had during my career was the unknown condition of equipment that had been used around patients and possible exposed to bodily fluids. I was worried about whether they could present a bio-hazard to repair and indeed the entire organ...
I'm curious to hear what other industry professionals feel about the Netflix documentary "The Bleeding Edge" that recently debuted offering a scathing exposé of our industry. My thoughts: For sure there are companies that have not always held patient...
How critical is ISO 13485 certification for design firms serving medical clients? Must have? good to have?not required?Thanks for your feedback,Philsource: https://www.linkedin.com/groups/78665/78665-6055436469441486848
If you are a medical device company looking to start up/relocate to anywhere in the USA, which state would you choose? What factors are most important in your decision making? Think about the following:Availability of skilled workers? Percentage of p...
Kristin Benokraitis
Director of Quality and Operations at EG-GILERO: A trusted partner for medical and drug delivery devices
December 2016
We are working with a pharmaceutical company who, in the past, developed a combination product (drug/device). Because the device was included in the drug submission, it led to many questions, specifically about the device, by the agency because both ...
I met medical device inventor Peter Harris yesterday. He invented LapProxâ„¢, a device for Laparoscopic Gastric Plication. Peter taught me as much about laparoscopy as one can learn over a lunch at the Mongolian Grill. I'll try to hit the highligh...
What is the ROI on products that are outsourced, depending on the products, and removal of head count when you can eliminate people in mfg by outsourcing?source: https://www.linkedin.com/groups/78665/78665-6007319912278736900