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In his insightful 10x Conference talk at http://medgroup.biz/Gulfo, Dr. Joseph Gulfo explained the official FDA mandate: To promote the public health by PROMPTLY and EFFICIENTLY reviewing clinical research and taking appropriate action on the marketi...

As originally asked by Hannibal Bray. My Totally Biased Argument FOR Surgical Sales Reps in the Operating Room & The 6 Qualities Outstanding Reps All Possess #medicaldevices #surgicalsales Did you know that when you go in for surgery or a hospital pr...

As originally shared by Julie Omohundro Principal Consultant at Class Three, LLC Thanks, Ginger. I've been thinking that if these devices pose low enough risk to support market entry based on certification alone, they pose low enough risk that they w...

I can't say enough good things about Mick Farrell, CEO of ResMed. He gave a delightful and informative keynote presentation at the 10x Medical Device Conference in May. You can watch the replay and download the slides and transcript at http://medgrou...

Despite ever-changing and increasingly complex medical device regulations, many companies have built their compliance systems on risky paper-based quality systems or legacy, general purpose software not built for med device. You can do better and we'...

Organizations today are faced with a growing list of new and changing standards, and keeping pace with them has become increasingly difficult. It’s hard enough to manage regulations in one country, much less multiple countries. How are the most effic...

Government agencies in the US, UK, EU and elsewhere now are mandating electronic product data submissions. And major customers including Group Purchasing Organizations and hospital networks need access to the data in a standard format. That’s where t...