FALLS CHURCH, Va. (PRWEB) July 15, 2020
Searching for the best way to fulfill the competing needs of various device identification requirements? Looking for the most efficient way to appropriately identify a product in different global markets?
The task of meeting unique device identification (UDI) guidelines can be complicated. Requirements around the world are evolving and despite efforts by the Global Harmonization Task Force and International Medical Device Regulator Forum to integrate global expectations, they are evolving in different ways in different places.
Even now, when the deadline for final implementation of Class I products is quickly approaching in the United States and UDI timelines in the EU remain unchanged due to COVID-19, regulatory bodies in other countries are starting to implement their own new programs.
UDI expert Jay Crowley will share ways to manage multiple regulatory bodies, best practices around establishing and maintaining robust and effective global UDI processes, possible responses to distinct local UDI concerns and how to submit identification product data to various stakeholders:
The Evolution of Universal Device Identification Guidelines:
- Impacts on device identification and product data
- Global development and implementation of UDI requirements
- Recommended shared data obligations
Intertwining Regulatory, Commercial and Patient-Safety Information:
- How regulatory complexities affect device manufacturers
- Ways manufacturers can work with stakeholders to guide and manage information
- National and local regulatory concerns: counterfeits, traceability, cost controls
Initial Development, Maintenance and Reuse of Information:
- Supporting global use-cases
UDI Best Practices:
- EU UDI requirements, including EUDAMED expectations
Finding the best way to meet shifting global identification obligations is a complicated balancing act. Learn how to navigate the process and discover the most effective, practical solutions to international UDI concerns.
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Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
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Meeting Global Unique Device Identification Requirements:
Regulation, Compliance, and Best Practices
An FDAnews Webinar
Wednesday, July 29, 2020, 1:30 p.m.-3:00 p.m. EDT
$287 per site
Easy Ways to Register:
By phone: 888.838.5578 or 703.538.7600
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