Free On-demand webinar

How and When to Register EU Medical Devices and Report UDI Information to EUDAMED

Watch the free webinar

 

If your medical device marketing strategy includes distribution into the European Union and other international markets, a comprehensive plan for managing and submitting Unique Device Identification (UDI) data to satisfy regulatory requirements is now on your to-do list.

Multiple regulators across the globe are emerging with regulations that require medical devices and in vitro diagnostic medical devices carry UDI. How will your organization respond to meet UDI data management around the globe?

Regulatory UDI requirements started with the FDA mandate in the US and now the EU Medical Device Regulation (MDR) becomes effective in less than 9 months on 26 May 2020. In parallel, your commercial business partners are starting to revise their contracts to specify UDI be placed on products and available electronically for published product catalogs.

We've teamed up with Reed Tech to share their expertise on the topic. In this 60-minute webinar, you'll learn how and when to register EU medical devices and report UDI information to EUDAMED and expected future challenges in implementing UDI. We will take a look at UDI data elements and review key differences of UDI between FDA and EU (some of which may surprise you). Lastly, we will cover advantages of a central product information management solution to prepare you in defining your UDI roadmap.

Specifically this webinar will cover: 

  • The known requirements to register medical devices and report UDI to the EU EUDAMED database
  • Step-by-step process for registering EU medical devices and reporting information to EUDAMED
  • Differences/similarities of FDA UDI (GUDID) and EU UDI (EUDAMED)
  • The advantages of a comprehensive, global strategy for UDI compliance
  • Q&A Session

Who should attend?

  • Unique Device Identification (UDI) Team Members
  • Global Strategy Business Managers
  • Regulatory Affairs/Operation Leaders
  • Product Managers and Business Analysts
  • Manufacturing, Operations, and Supply Chain Leaders
  • Quality Leaders

Presenter

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Gary Saner
Sr. Mgr. of Information Solutions Life Sciences
Reed Tech

Moderator

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Jon Speer
Founder, VP of QA/RA
Greenlight Guru

 
 
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About 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.

 

 

 

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ABOUT REED TECH

Reed Tech is the provider of best-in-class data management, conversion and analytics solutions provider to government agencies, the intellectual property market and the life sciences industry. Our solutions offer the means for our customers to reach higher levels of productivity and efficiency and to gain control over their data and take action. Our offerings enable the collection, transformation, submission and analysis of data. The corporate culture is driven by a commitment to excellence, innovation, and a strong dedication to its customers, employees and communities. Reed Tech is a LexisNexis company. For more information, please visit ReedTech.com.

 

 

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