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UDI Data Submission

  • Reed Tech Announces Agreement with GDSN Data Pool Solutions Provider 1WorldSync

    Reed Tech Announces Agreement with GDSN Data Pool Solutions Provider 1WorldSync

    This agreement will allow Reed Tech customers to access the Global Data Synchronization Network (GDSN) and provide 1WorldSync customers with expanded options for managing their regulatory data.

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  • GS1, GTIN, GDSN--What do they have to do with UDI?

    GS1, GTIN, GDSN--What do they have to do with UDI?

    If you are involved in your organization’s compliance program for Unique Device Identification (UDI), you have probably heard a lot of “G terms” being thrown around, like “GS1,” “GTIN” and “GDSN.”

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  • UDI Post-GUDID Publishing Webinar1:00:16

    UDI Post-GUDID Publishing Webinar

    UDI expert John Lorenc of Reed Tech examines post-submission UDI data maintenance and data management responsibilities and strategies.

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  • UDI Data Security: Why it should be important to you

    UDI Data Security: Why it should be important to you

    Data security has three facets—confidentiality, integrity and availability. Device labelers need to keep each of these areas in mind when it comes to managing the UDI data for their device portfolio.

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  • Data Submitted! But the UDI Journey Continues...

    Data Submitted! But the UDI Journey Continues...

    September 24 and the Class II UDI deadline compliance date is past. But UDI is not over. For medical device labelers, it will always require maintenance and ongoing work. UDI is the new normal.

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  • UDI Data Submission Case Study: Henry Schein

    UDI Data Submission Case Study: Henry Schein

    As the Henry Schein team was faced with collecting...and maintaining all of this data for each product in U.S. distribution, they realized the process would be extremely time consuming.

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  • Time is Up! Class II UDI Deadline Tomorrow

    Time is Up! Class II UDI Deadline Tomorrow

    For those of us who have been working on UDI for months or years, it may seem hard to believe that tomorrow is already the FDA’s Class II UDI compliance date.

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  • UDI Q&A with Jay Crowley and Gary Saner1:01:48

    UDI Q&A with Jay Crowley and Gary Saner

    On September 8th, 2016, UDI experts Jay Crowley (USDM) and Gary Saner (Reed Tech) took questions live from industry members working to meeting the September 24 deadline for Class II medical devices.

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  • FDA UDI Class II Extension: Does it apply to your products?

    FDA UDI Class II Extension: Does it apply to your products?

    This week, the FDA issued a letter extending the UDI labeling and data submission compliance date to 2018 for certain categories of Class II devices.

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  • UDI: Best Practices in Data Management, Barcoding and Direct Marking51:08

    UDI: Best Practices in Data Management, Barcoding and Direct Marking

    UDI experts Gary Saner (Reed Tech) and Michael Barron (Domino) discuss best practices for medical device labelers seeking to comply with the FDA's Unique Device Identification mandate.

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  • Just 25 Business Days Remaining Before the Class II UDI Deadline!

    Just 25 Business Days Remaining Before the Class II UDI Deadline!

    If your company markets Class II devices in the U.S., have you successfully submitted your UDI records to the FDA? If not, are you on the path to full compliance within the next 25 business days?

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  • What's the real cost of UDI compliance?

    What's the real cost of UDI compliance?

    UDI team leaders should ask themselves these important questions about the total costs of their UDI data submission and management plan.

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  • FDA UDI Enforcement5:18

    FDA UDI Enforcement

    How will the FDA enforce the requirements of the UDI Final Rule? This video details what the FDA has said so far and what we can expect for UDI policing based on prior agency enforcement tactics.

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  • Should you DIY UDI?

    Should you DIY UDI?

    DIY is a growing movement. But for DIY projects, you should always use the right tool for the job and take advice from an expert. Is DIY for UDI the right approach for your organization?

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  • UDI Post-Submission Responsibilities

    UDI Post-Submission Responsibilities

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  • Labeling or Data Submission, Which UDI Step Comes First?

    Labeling or Data Submission, Which UDI Step Comes First?

    When I speak to medical device industry members about the FDA’s requirements for submitting their UDI data to the GUDID, I am frequently told they are not worried about that aspect yet. I often...

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  • UDI Pitfalls & Best Practices for Labeling and Data Management45:16

    UDI Pitfalls & Best Practices for Labeling and Data Management

    UDI experts Gary Saner (Reed Tech) and Lee Patty (NiceLabel) discuss UDI problems encountered by medical device labelers and the strategies employed to overcome them.

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  • FDA UDI Enforcement: 4 Things to Consider

    FDA UDI Enforcement: 4 Things to Consider

    While recently speaking with a regulatory manager who works at a medical device manufacturer with a large Class II product portfolio, I was surprised to hear that his organization was not...

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  • UDI Submission Load Testing

    UDI Submission Load Testing

    As I talk to medical device industry members about their plans for UDI, I continue to find many organizations that have not yet begun making their submissions to the GUDID. A lot of labelers have...

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  • HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface

    HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface

    Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product Labeling...

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