This webinar will provide updates on the progress of unique device identification regulations around the world, including the status of the FDA’s implementation, requirements for UDI in the new EU MDR, the NHS e-procurement and PEPPOL programs in the UK, and the development of initiatives in other countries including Australia, Canada, Japan and Asia.
Unique identification and barcoding are neither new technologies nor innovative concepts. But incorporation of UDI into the medical device industry has been long discussed and planned and slow to be implemented.
What has taken this major industry so long to adopt UDI and barcoding? Why are both manufacturers and hospital systems reticent about implementing it?
Why Should You Attend:
Knowledge, planning, preparation. These are the foundation principles for any successful and sustainable project, especially one as global and multi-faceted as Unique Device Identification. It is never too soon to begin increasing your awareness of the various programs being established and your knowledge of the requirements and timelines to help you begin planning and preparing for what is inevitably going to be a challenging, resource-heavy, and time-consuming process.
Medical device manufacturers of all sizes, locations, product class, and expertise are in the same precarious position of uncertainty and waiting. By strengthening your UDI intelligence now, you will be better positioned to lead your organization in this global initiative.
Areas Covered in this Webinar:
Intent of Unique Device Identification regulations
Why are countries creating regulation for UDI?
What is the purpose of the regulation?
Current efforts & hurdles to harmonization
Key differences in proposed regulations
Comparison of IMDRF/ US FDA/ EU
Timelines – known & anticipated
Impact of UDI on global trade & commerce, product cost, and patient safety
Be aware of what UDI information to look for and where to find it
Be able to outline a general UDI strategy by identifying and prioritizing the “critical to business” regulations you need to address first
Who Will Benefit:
Regulatory Affairs Professionals
Quality Assurance Professionals
Master Data Managers
Supply Chain Professionals
Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as Director of Operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.
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