Question
FDA detractors have long complained it's faster and easier to earn a Conformité Européen (CE) mark versus FDA clearance. Is that about to change? Maybe, in light of revised text for new regulations proposed by the European Commission. You can partial...
As you know, medical devices sold in America require FDA clearance.Is gaining FDA clearance more stringent than obtaining a CE mark? And a question for regulatory experts in our group: Is it defensible for your sales reps to say to a prospect, "Well,...
I have two clients who source parts from – you guessed it – Wuhan, China. One's basically out of business, so he postponed a medical device marketing project with me. Then there's the 10x Medical Device Conference in April. My beloved alumni say, "Un...
Medical devices companies use modelling and simulation in the design phase but it's now possible in principle to produce evidences of safety and/or efficacy using computer models, something called In Silico Trials.FDA has produced guidelines, and the...
Barring the completely unforeseen, the medical device tax will be permanently repealed before Christmas 2019. There was no debate. Instead, as Andre DiMino explained on MDG Premium, tax repeal was swept up into the second of four omnibu...
What's the best way to achieve my goal? I've been Product Manager at Dentia Innovations in Bengaluru, Karnataka, India for more than three years. Do I take classes?
Engineering Innovation: From Idea to Market Through Concepts and Case Studies is a comprehensive resource for aspiring entrepreneurs of all professional backgrounds, including academics, clinicians, engineers, and scientists. Engineering Innovation d...
I am a very hard working individual, and a very passionate person. I have skillsets and experiences that are easily transferable. I would like to be employed and hopefully work for same organization for long time. I am also ready to learn any new ski...
Amy DeWinter
Founder, Ascenda Medical Marketing | Expertise in Advancing Medical Technology
November 2019
Hello, Med Device Community. I am consulting with an early commercialization company that has a device used in emergent situations, so use is not planned. Our challenge is trying to collect evaluation forms for prospective accounts with the intention...
Caitlin Morse, PMP says you can minor in biomedical engineering, but – for your sake – don't major in it. If you do, you won't likely start as an engineer. Caitlin says, Many who are excited about going into medical device or other life science compa...
