Unique Device 2020 - Meeting Global Unique Device Identification Requirements

Requirements around Unique Device Identification (UDI) are evolving. Despite efforts by the Global Harmonization Task Force and International Medical Device Regulator Forum to integrate global expectations, national guidelines have continued to develop in differing ways.
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.
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
Speaker:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation