UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as EUDAMED requirements are becoming stable.
This webinar will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements.
The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
What are the 6 Modules of EUDAMED
Current voluntary activity, what to do now
IVDR DoA is May 16, 2022 – updated implementation timeline
Reporting UDI data
Labels UDI data
How can Reed Tech Help?
Q&A session
Global Strategy Business Managers
Regulatory Affairs/Operation Leaders
Product Managers and Business Analysts
Manufacturing, Operations, and Supply Chain Leaders
Quality Leaders
IT Support
Gary Saner
Sr. Manager, Information Solutions Life Sciences
Reed Tech
John Lorenc
Director Product Management, Medical Devices
Reed Tech
Tom Rish
Senior Medical Device Guru
Greenlight Guru
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient.
Visit our homepage to learn more.
Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.
Visit their website to learn more.