Med Device Link Newsletter - Nov 2023

As we gear up for the holiday season and prepare to wrap up the year, we want to remind you that we are here to support staying current with the latest UDI requirements. If you need assistance updating your FDA GUDID records or getting ready for UDI submissions to global health authorities, please don't hesitate to contact us via email at [email protected].

Webinar Recordings

Ask the Experts: Basic UDI-DI Part II

Gary Saner and Ronald Boumans answer questions and provide scenarios regarding Basic UDI-DI for EU EUDAMED.?

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Ask the Experts:?Critical Steps in Implementing Your EU MDR/IVDR Plan

Gain valuable insights and expert advice from Gary Saner and Tommy Roy Rosholt as they address your queries and present practical scenarios for implementing your EU MDR/IVDR plan.

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Industry News and Blogs

Navigating the AusUDID Rollout: A New Era for Medical Device Identification

?In this blog, we will explore the significance of the AusUDID rollout, its objectives, and how the TGA requirements for UDI differ from FDA regulations.

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Update on Draft EUDAMED Timeline?

The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project. This blog covers the most recent updates to the EUDAMED timeline.?

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Reed Tech Insights: EUDAMED Draft Timeline Deep Dive

In this short video, Gary Saner walks through the European Commission's recently released draft of the updated EUDAMED timeline.?

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State of the MedTech Industry Survey

It's that time of year again! Please take some time to complete the annual survey conducted by our friends at Greenlight Guru.

?Details:

• Open until November 13, 2023?
• It takes less than 10 minutes to complete ?
• All answers will be completely anonymous - a 3rd party research firm conducts this survey?
• Participants get free, early access to the research report?
• Upon completion, participants can enter our drawing to win a $100 gift card of choice, plus $100 donated to Project Cure in their name.?

Access Survey

Introducing the 'Understanding UDI Series'

Access the 'Understanding UDI Series' for short tutorials and quick reference slides. Learn more about regulations, requirements and timelines for Global Health Authorities. We added a recent update for Australia. How did you score on the quiz??

Unlock the Series

Questions? Ask the Experts

If your team has questions about health authority requirements, device classes, Unique Device Identification (UDI) data attributes, or related topics, get in touch! We'd be happy to help.

[email protected]