Preparing Data for EUDAMED: A Virtual Panel, Upcoming Webinar Hosted by Xtalks

For regulatory teams working on EU MDR/IVDR data, this webinar will be a helpful walk-through of the main takeaways in the published information from the European Commission and the Medical Devices Coordination Group concerning current state and future.

News provided by

Xtalks

Oct 05, 2021, 08:30 ET


TORONTO, Oct. 5, 2021  Register for this webinar for a virtual panel discussion of some of the critical questions being asked about medical device requirements for global health authorities with special emphasis on EU EUDAMED. The panel will discuss topics like:

  • What should I know about existing CE marking and future requirements?
  • For IVDR, who decides what class a product falls into and can I 'self-certify' under the IVDR?
  • Are there some products that have resulted in reclassification to a 'higher class' for EU-MDR? What are some examples?
  • When the UDI/Device Registration Module opens, will EUDAMED already be populated with existing 'Directive' device info? If I participate in the voluntary period, does that count as an 'official' submission or do I re-submit when EUDAMED goes live?
  • For EUDAMED device registration, what is the difference between Regulation and Legacy requirements?
  • What Quality Management changes need to occur to comply with MDR/IVDR?
  • What are the main differences between GMDN and EMDN? Is mapping available between the two standards?

Join expert speakers from Reed Tech, Gary Saner, Sr. Manager, Information Solutions Life Sciences; and John Lorenc, Director Product Management, Medical Devices; as well as Mark Wasmuth, CEO, The GMDN Agency; Tom Rish, Medical Device Guru, Greenlight Guru; and Erin Salbilla, Director of Quality Systems, Vyaire Medical, in a live webinar on Thursday, October 21, 2021 at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit Preparing Data for EUDAMED: A Virtual Panel.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Media Contact

Sydney Perelmutter, Xtalks, +1 (416) 977-6555 x 352, [email protected]

SOURCE Xtalks