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    Question
    Steve Bixby
    Director, International Sales & Marketing at MorTan, Inc.
    February 2016
    What are the FDA labeling requirements for disposal of a medical device?
    Is anyone aware of the FDA guidance documents to say what medical devices require specialized instructions for disposal? I’m not talking about ones with obvious hazards such as implantables or ones with sharps, but simple Class I single-use devices. ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    October 2013
    How do you spot an 'Ugly baby' within the new product development process and stop it?
    As originally asked by
    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...
    Gautam Sharma
    Vice President at Pathshodh Healthcare Pvt Ltd
    May 2016
    Barcoding on Medical Device
    Is it mandatory to have GS1 GTIN barcoding on medical device? I understand US FDA has made UDI mandatory, but for a company which is not targeting US market is it good to have a GS1 GTIN barcoding in place. source: https://www.linkedin.com/groups/786...
    Ken Steinberg
    CEO/Founder, Cambridge Research & Development
    August 2014
    What are the most widely used non-metalic materials for laparoscopic instrument arms?
    source: https://www.linkedin.com/groups/2526855/2526855-5905909540020310019
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    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...
    Minakshi Mohanty
    Medical Device Engineer (Research & Development)
    September 2018
    How to Design Protocols?
    There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.Let’s say I am designing a PCB and have to write a protocol to test ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2013
    If anyone can reference a good contract manufacturer to pouch and final pack simple devices in a quick turn around, please contact me.
    As originally asked by Joe Braido. If anyone can reference a good contract manufacturer to pouch and final pack simple devices in a quick turn around, please contact me. James Wisser President at Pinehurst Plastics Robling Medical - Brent Robling is ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    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...
    Barbara Ressler
    Cell Therapy Product Development Lead at Duke University Health System
    December 2016
    Design Control Industry Meeting Recommendations
    I'm looking for a good industry conference on the "geekier" side of med device development--design controls, quality systems, FDA regulations, user need assessment, etc. Has anyone attended an industry meeting on these topics that was useful and stim...
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