Question
A group member wrote saying he's developed a first-of-its-kind medical device – one that would require a large capital investment from physician offices. He established distribution with two large national distributors and has reimbursable CPT codes....
I had recently come across a company that does genetic risk testing for Interleukin, a biomarker that shows a predisposition to inflammatory responses.Periodontal inflammation (Periodontitis or gum disease) and chronic diseases such as diabetes and c...
My husband and I both work in medical devices. Lately, we have been brainstorming ways to improve access to healthcare by reducing device cost (DFx), simplifying training or required practitioner skill level to operate device, less dependence on reli...
As originally asked by Divya G. EU representative for CE marking: is Israel consider an European address in your point of view? Julie Omohundro Principal Consultant at Class Three, LLC Divya, just put your cursor over Stacy's name next to her comment...
Dr Ali A.Mohamedi
Dr Ali A.Mohamedi ,Director @ Senator Medical Sweden (+30 K LinkedIn followers)
November 2016
Will appreciate to have your inputs/experiences..source: https://www.linkedin.com/groups/78665/78665-6200314781845508099
Just had an article referred to me about ISO 14971 that we all should read. It was a written by an academic researcher in product safety risk management and discusses the merits of ISO 14971.https://onriskof.com/2016/10/03/medical-device-risk-iso-149...
source: https://www.linkedin.com/groups/2070960/2070960-6200379152344846338
Im wondering how you would list your device if you buy it in bulk, off the shelf, non sterile then you sterilize the device. Are you a manufacturer 9becasue you have performed an additional process to the device) or a repackager/relabeler? Any though...
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 ...
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