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    Amy DeWinter
    Founder, Ascenda Medical Marketing | Expertise in Advancing Medical Technology
    November 2019
    Product evaluation collection - looking for ideas
    Hello, Med Device Community. I am consulting with an early commercialization company that has a device used in emergent situations, so use is not planned. Our challenge is trying to collect evaluation forms for prospective accounts with the intention...
    Joe Hage
    πŸ”₯ Find me at MedicalDevicesGroup.net πŸ”₯
    September 2019
    Did you know the packaging rules changed this year?
    I had been trying to get a packaging expert on the 10x stage for three years because we'd never covered it in depth as a group. It was worth the wait. Adept Packaging sent 35+ year veteran Jan Gates to speak and she did not disappoint. This video is ...
    Joe Hage
    πŸ”₯ Find me at MedicalDevicesGroup.net πŸ”₯
    April 2019
    What you need to know about post-market data
    In layman's terms, post-market data means regulators want to know how your market is doing in the marketplace. Christine Zomorodian and Anne Leijsen gave an easy-to-follow talk about it at the 10x Medical Device Conference in October, 2018. Before we...
    Joe Hage
    πŸ”₯ Find me at MedicalDevicesGroup.net πŸ”₯
    March 2019
    MDR labelling requirements -UDI
    As originally asked by
    Joe Hage
    πŸ”₯ Find me at MedicalDevicesGroup.net πŸ”₯
    March 2019
    How To Use Human Factors To Mitigate User Risk
    If you want an education about human factors, who better than a university professor who is an AAMI chair to teach it? I have the recording, slides, and transcript from MaryBeth Privitera's 10x talk for you today. Human Factors: MB's Main Takeaways U...
    Joe Hage
    πŸ”₯ Find me at MedicalDevicesGroup.net πŸ”₯
    January 2019
    I'm struggling to convey the importance of this
    I'm really hoping this message gets out to anyone planning a clinical trial, so please forward it to your network. This is an ambitious post, sharing two great 10x Conference presentations.Doug Fankell, Ph.D. (on left) is an engineer with Structural ...
    Joe Hage
    πŸ”₯ Find me at MedicalDevicesGroup.net πŸ”₯
    January 2019
    What You Need to Know Before Manufacturing a Wearable Device
    That's a fancy health tracker on your wrist. Is it medically accurate? Tracking devices – monitors, if you will – have been around for a long time. In the intensive care unit, the patient is monitored 24 hours. Your fitness tracking device may not ev...
    Whitney Lewis
    Quality Assurance Specialist at Blackrock Microsystems
    November 2018
    How to determine when to label a medical device as investigational use only
    Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?The devices are not cleared and some may or may not be on a path to...
    Joe Hage
    πŸ”₯ Find me at MedicalDevicesGroup.net πŸ”₯
    November 2018
    Is That Contract Manufacturer a Good Fit for You?
    If you make the selection just on cost, in about a year, you may be very sorry about the decision you made, began Mark Rutkiewicz, VP, Quality at Innovize. His was a really solid talk. I'll share the first of his five questions here. You can find the...
    Emily Saba
    Research and Development Intern at NCGrowth
    November 2018
    ER Vital Wristband Input
    I’m currently a student at the University of North Carolina at Chapel Hill, studying economics. I am taking an Entrepreneurship class, where we must create a venture in relation to health care.My group has come up with an idea to create wristbands th...
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