Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium

Community

Start a Discussion
    • Newest
    • Most views
    Question
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    March 2019
    MDR labelling requirements -UDI
    As originally asked by
    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...
    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...
    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...
    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
    Anthony Molliex
    Quality and Regulatory Affairs Director chez Arthesys S.A.
    October 2016
    End of Own Brand Labelling (OBL) procedure ?
    I would like to know if some of you have issues with this procedure ? What is your Notified Body and does it still accept OBL procedure for CE marking ? I think that is a huge concern for many Medical Device companies and it deserves a discussion. so...
    Shanshan (Samantha) Chen (ASQ CQA)
    RA/QA professional in Medical devices industry, seeking to new opportunity.
    August 2016
    Any labelling requirement for medical device’s Wi-Fi function in Canada?
    Do anybody know that is there any labelling requirement for medical device’s Wi-Fi function in Canada? I check the label regulation and they did not mention Wi-Fi, thanks!source: https://www.linkedin.com/groups/2070960/2070960-6176002121310175232
    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...
    1 2 Next »

      Stay connected with us.

      By signing up you are agreeing to our Privacy Policy.

      Categories

      • Capital/Investment
        • Business Model
        • Funding
      • Careers
      • Design/Devel
        • Design
        • Development
        • Human Factors
        • Labeling
        • Material Selection
        • R&D
        • Trials and Post-Market
      • Featured
      • Industry
        • Announcements
        • Device Tax
        • Hospital and Health Care
        • Innovation
        • Medtech
      • LinkedIn, etc.
      • Markets
        • Africa
        • Americas
        • Asia
        • Australia
        • Europe
      • Regulating
        • CE Marking
        • EU
        • FDA
        • FDA/EU etc.
        • Notified Bodies
        • Quality
        • Regulatory
      • Selling
        • Distribution
        • Intellectual Property
        • Marketing/Sales
        • Reimbursement
      • Worth bookmarking!
      Featured Job

      You Won’t Want to Miss a Thing.

      We’re working to make MedicalDevicesGroup.net the world’s most useful site to serve the medical device industry.

      By signing up you are agreeing to our Privacy Policy.

      logo

      Companion to LinkedIn's 350,000 member community

      • Contact
      • Medical Device Marketing
      • In Memoriam
      • Medical Device Conference

      The Medical Devices Group   |   Copyright © Terms, Conditions & Privacy

      Medical Devices Group
      Powered by  GDPR Cookie Compliance
      Privacy Overview

      This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

      Strictly Necessary Cookies

      Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

      If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.