Regulatory Open Forum

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  • 1.  Labeling software for medical device

    Posted 07-Dec-2022 17:49


    Looking for recommendations for off-the-shelf software that allows for the design, printing, and change control of medical device labels (product labels only, not IFUs), ideally one that is suited for a small company without a dedicated IT department.

    Thanks in advance!

    Vineet K. Sarin, Ph.D.

    President & CEO

    Kinamed, Inc.





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    Vineet Sarin PhD
    President & CEO
    Camarillo CA
    United States
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  • 2.  RE: Labeling software for medical device

    Posted 08-Dec-2022 00:34
    Dear Vineet,

    Consider Barone software by Zebra in your search. This company might support your needs.

    Best regards,
    Kristine Tkacs

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    Kristine Tkacs RAC
    Regulatory Affairs Management
    Branchburg NJ
    United States
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  • 3.  RE: Labeling software for medical device

    Posted 08-Dec-2022 01:42
    Hello Vineet,

    I could recommend the same, Zebra printers are quite commonly used in the medical device industry (and other industries) for on-demand printing of labels.  I used them myself and the associated software when working in smaller companies.  You can get pre-printed labels with logos and such, then print mostly anything, even symbols.  There are a few other third-party applications which work with Zebra printers too which could look at like their own in-house version, BarTender, Loftware, etc.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: Labeling software for medical device

    Posted 08-Dec-2022 09:38
    We use Codesoft with Label Archive.  It works great with both HIBCC and GS1 bar codes and gives us a complete revision history within Label Archive.  We are a smaller company as well.  We currently use the software with both thermal transfer (Zebra) and laser printers. 

    https://www.teklynx.com/en/products/enterprise-label-management-solutions/label-archive

    https://www.teklynx.com/en/products/label-design-solutions/codesoft

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    Alyssa Roelli
    Senior Regulatory Projects Manager
    Milwaukee WI
    United States
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  • 5.  RE: Labeling software for medical device

    Posted 09-Dec-2022 20:56
    EZ mabel software is cost effective and good for small company. just purchase the software, design your own label with symbols and hook it up to a datamax printer You should be good to go..

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    Bedwuine Senatus
    QA/RA Director
    Springfield NJ
    United States
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