Unique Device Identification (UDI): The Latest Developments and Preparation for Upcoming Deadlines

1 Hour Video | MJ Wylie and John Roberts, GS1

With the clock ticking on the upcoming September 24, 2014 deadline for Unique Device Identification (UDI) requirements on class III medical devices, manufacturers need to be actively applying resources and building processes to reach UDI compliance. In order to ensure timely and accurate UDI implementation, device manufacturers must submit device data earlier than required to leave time to address any errors and avoid potential hurdles in the submission process.

  • Reviewing milestone deadlines
    • Defining FDA UDI exceptions and alternatives
    • Outlining qualifications for deadline extensions
  • Preparing for Global Unique Device Identification Database (GUDID) submissions
    • Identifying product with UDI
    • Acquiring and managing required data elements
    • GUDID data submission and maintenance
  • Forecasting developments for Class I and II devices

 

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Quality Assurance
  • Supply Chain

 

 

This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.

 

 

 

MJ Wylie photo

 

 

 

 

 

MJ Wylie
Senior Director, Healthcare
GS1 US

As a Senior Director of Healthcare for GS1 US, MJ Wylie is responsible for leading U.S. healthcare trading partners to actively engage, adopt, and implement GS1 Standards to improve their business and supply chain operations. With a focus on the Medical Device Segment, she is passionate about helping the industry comply with the FDA’s UDI (Unique Device Identification) rule for enhanced patient safety.

Prior to joining GS1 US in 2012, Ms. Wylie has consulted on global standards and UDI for multiple stakeholders. She previously spent 10 years working for GHX, where she held various roles related to content management and global data standards with an international focus. As Director of Global Data Standardization, Ms. Wylie led GHX to be a GDSN-certified data pool for healthcare trading partners. She has worked with leading standards and advocacy organizations as well as governments, and continues her work with global standards to improve business, clinical, and supply chain efficiencies. Ms. Wylie is a Certified Global Regulatory Affairs Compliance Professional (GRACP) and an active member of the National Speakers Association (NSA). She graduated with a BS in Technical Communication from Colorado State University.


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