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    Question
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2013
    Does anyone know whether a new research application (non-510k approved use) of a software medical device can be placed in an existing 510k approved product?
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    December 2015
    Preparing for 2016
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2014
    Big Data Analytics and the Transformation of Healthcare
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2014
    When, in your company’s lifetime, did you get your quality system?
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    December 2013
    Documentation groups and standards?
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2016
    Top 12 Posts from 2015 (Medical Devices Group)
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    November 2013
    Ultrasonic Thermometry
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2013
    Is anyone aware of or familiar with any midwest-based companies involved with production and/or support of medical devices related to diabetes?
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2014
    Class III: Out of Time
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2014
    If You're Considering International Markets...
    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...
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