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Help with FDA UDI Compliance

This week we got together with a very motivated group of medical device manufacturers, as well as friends from Zebra Technologies and Flexcon, to discuss how to come up with a plan to meet the FDA’s new UDI Rule.

Since the ruling was only published in late September, there were a lot of great questions and we had some really good interaction.

As well as presentations, guests also had the opportunity to see live demonstrations on how labels are designed to meet the GS1 and HIBCC standards and then printed on Zebra barcode printers. We also demonstrated thermal transfer overprinting for flexible packaging and laser marking for direct part marking.

We appreciate that our guests took time out of their day to visit with us and the support of our great partners.

If you are in the medical device industry and missed the event, we are sure to hold another at some point so let us know if you are interested. We are also happy to bring the seminar to your facility or put on an online version.

Here is the slide deck from the event:

Are you in the medical device business? How can ID Technology and our partners help you with your UDI plan? Call me at 603-598-1553 x237 to get started or use the contact form on the site.

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Comments

  1. Thank you, David Holliday, for the great Slides and the Presentation.
    Just one remark on the time scale slide:
    AFAIK, the requirement for DPM for Implants was dropped by the FDA.
    Only items which are reused or sterilized by the customer must be marked if technically possible.

    Enjoy 2014,
    Harald

  2. David Holliday says:

    Thanks for the comment, Harald. You are correct, the requirement for implantable items to need DPM was removed from the proposed rule when the final one was published – unless it is an item that is reused.

    Of course, these would still need to have the UDI labeling on the packaging.

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