This webinar will give an update concerning Unique Device Identifier (UDI) preparation focused on EU EUDAMED UDI and device registration, plus any newly-posted guidance and data dictionary information concerning the six EUDAMED modules. Additionally, the speakers will report on global health authorities including South Korea MFDS, China NMPA and other regions.
Register for this webinar and bring your specific questions concerning UDI, medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions.
Speakers
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.
Message Presenter
John Lorenc, Director Product Management, Medical Devices, Reed Tech
John Lorenc directs electronic submission and regulatory requirement initiatives that impact the medical device industry. He has advanced experience with machine-to-machine submission requirements to global UDI databases, including US FDA GUDID, EU EUDAMED, and China NMPA UDID.
John represents Reed Tech in membership with MedTech Europe, and actively participates in electronic submission pilots to regulator UDI databases.
Message PresenterWho Should Attend?
- Global Strategy Business Managers
- Regulatory Affairs/Operation Leaders
- Product Managers and Business Analysts
- Manufacturing, Operations and Supply Chain Leaders
- Quality Leaders
- IT Support
What You Will Learn
In this webinar, participants will learn about:
- Preparing for EUDAMED UDI submissions
- What you need to know for EUDAMED device registration
- An update on other global health authorities
- How Reed Tech can help
Xtalks Partner
Reed Tech
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.
Life Sciences Solutions Driven by Accuracy and Insight
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.
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