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    Elizabeth Doyle
    Mechanical Engineer excited to design and manufacture medical devices and assistive technologies.
    March 2018
    Biocompatible materials
    I've been trying to find a list of materials approved for implant by the FDA with little luck. Can anyone point me towards such a list? Or do you have a personal list compiled over the years that I could use as a reference point? Application-wise, ri...
    Dr. Andrew Whitehead
    Director - Executive - Consultant
    March 2018
    Clinical Research Organisations
    Looking for recommendations on Clinical Research Organisations to undertake phase 1/2 clinical trials for a newly developed medical device and a therapy.source: https://www.linkedin.com/groups/78665/78665-6380263623817719811
    Rob Packard
    Ship & Print Your FDA eCopy
    March 2018
    Labeling Integration Solution for FDA & EU Compliance through SAP
    Tomorrow there is a medical device webinar from PRISYM ID on how to successfully integrate SAP with your label lifecycle management solution. This solution will accelerate your business processes through end-to-end automation. Integration benefits in...
    Dave Fornell
    Editor - Diagnostic and Interventional Cardiology (DAIC) at Scranton Gillette Communications, Inc.
    November 2017
    5 Tips for Medical Device Engineers on FDA Design Controls
    5 Tips for Medical Device Engineers on FDA Design ControlsIf you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel lik...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2017
    The Dexcom Labeling Change That Really Helped Diabetics
    For 10 years, Dexcom made this claim: Continuous glucose monitoring (CGM) is intended to supplement, not replace, a blood glucose meter. A confirmatory finger stick is required prior to treatment. This is known as an adjunctive claim, because the mon...
    Sharon Shachar
    QA Director at Medtronic (former Given Imaging)
    February 2017
    Packaging validation
    Can someone share what and how he is doing packaging and labeling validation for a non sterile product ? Quantities? Parameters ? Forms ? How many batches ? source: https://www.linkedin.com/groups/2070960/2070960-6232416918385487874
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    December 2016
    ISO 14971:2016 and Labeling
    As originally asked by Erin Seiler, MBA Account Manager, Color & Additives North America at PolyOne A huge trend in labeling we are seeing on the manufacturing end, is a change from stickers or other forms of identification to laser marking technolog...
    Patrick Baranczak
    Responsable Production chez Sonoscanner
    December 2016
    UDI label creation software
    I am using Avery labels on a A4 sheet and a desktop laser printer. Can anyone suggest me software to create labels with a bar code type GS1-128 Datamatrix? I found the software "Nice label pro" that would suit me, is there any other on the market? Th...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    December 2016
    Hi just curious, what type of label printer do medical device industry usually use to print labels efficiently ? Thanks
    source: https://www.linkedin.com/groups/78665/78665-6211618860588761089
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