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Barring the completely unforeseen, the medical device tax will be permanently repealed before Christmas 2019.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 happens after a customer calls in with a question, complaint, or need? If you handle the call, hang up, and move on to the next caller, you're missing a big opportunity, says Sarah Wright, Director of Global Customer Support, Healthcare Informat...
As per process validation definition in ISO-13485 and FDA CFR 21 Part 820 I have a concern where help from groups members is really appreciated,Recently I read a procedure that states that, since regular lots size are too big, sampling can be conduct...
Director of Corporate Development for Medtronic Mark Pacyna presented "How to Catch the Attention of a Medtronic" at the 10x Medical Device Conference. Among his quotables: "If you can’t improve outcomes, expand access, optimize efficiencies within t...
What (exactly) does it take to orchestrate and command a successful launch of an entirely new medical device? Such as a device that can be categorized as the "next revolution" in a medical specialty and/or represents a disruptive technology. I am par...
I'm very interested in your take on this. Mahesh Mulumudi, MD, is Division Chief of Medicine for Providence Regional Medical Center. He probably has as much influence on hospital buying decisions as any clinician there. Which made his comme...
Thank you for your time and congratulations on your involvement in Medical Devices. I am writing because I am considering a shift in career toward medical device manufacturing. My background is management of high-tech/computer manufacturing and test ...
This is my new stock answer whenever a medical device hopeful needs capital. Fill out this form. If you can't answer the questions on this form, your prospective investors ("smart money," if you will) don't have enough information. Take your pick: as...
Rob Packard tells me the three most common ways companies wreck their FDA submissions are: Wrong pathway. They take the wrong pathway. Say, a 510(k) instead of a De Novo. Wrong test. They spend their money on the wrong tests. Ignored advice. They ign...
I have a question regarding used/refurbished devices, Does anyone know which countries are allow to sell them? and the regulations? source: https://www.linkedin.com/groups/78665/78665-6017094814523285506