Question
As originally asked by Stuart Swibel. We have a new application that uses most of the same algorithms contained in our existing 510K approved product although this particular application use is not covered in our original 510k filing. Ideally, we wou...
With light readership during this holiday week, I want to thank you for being a member of this community. It's a pleasure to serve you. Take advantage of these Medical Devices Group resources for a successful 2016: MARKETING AND SALES TRAINING (Febru...
If you're in the business of collecting and using healthcare data to improve patient outcomes, have I got a treat for you. http://medgroup.biz/big-data-healthcare-transformation That's a link to the complete 10x talk by Dr. Marty Kohn, formerly the C...
When you began your medical device company, you had an idea – and maybe a prototype, funding, and some customer interest. At what point did you start implementing a quality system? It's required to generate the product documentation for regulatory ap...
As originally asked by
In 2015, the Medical Devices Group surpassed 300,000 members. We gave eight free webinars, hosted the third annual 10x Medical Device Conference, and many of us met in person, talked here, and made valuable business connections. Here are the most pop...
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As originally asked by
If you manufacture Class III medical devices, you've got a panic-inducing 71 days to comply with Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) guidelines. Are you ready? http://medgroup.biz/UDI-goes-in-ef...
At this year's 10x Medical Device Conference, Seth Goldenberg Ph.D., Senior Principal Scientist at NAMSA, gave an illustrative talk entitled, "Thinking Globally During Medical Device Development: Accelerating Products to International Markets." The f...
