Industry: Healthcare

FDAnews Announces — Understanding UDI in EU Device Regulations Webinar, Nov. 21, 2019

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FALLS CHURCH, Va. (PRWEB)

Understanding UDI in EU Device Regulations

An FDAnews Webinar

Thursday, Nov. 21, 2019, 1:30 p.m. – 3:00 p.m. EST

https://www.fdanews.com/understandudi

Are EU device and IV diagnostics sales in jeopardy?

It’s not a trick question. The last major compliance hurdle to new EU device regulations —UDI — is ahead, and many device and diagnostics makers simply aren’t prepared.

Not yet anyway.

Mark the calendar for Thursday, Nov. 21, when device regulation expert Dan O’Leary lays out the challenges of complying with unique device identification (UDI) rules … explains major variances from FDA regulations … and helps attendees meet the May 2020 deadline:


  • Overview of the EU’s UDI system

  • Requirements for devices and packages

  • The Basic UDI-DI: Its role and uses

  • EU-MDR Article 120 transition requirements

  • The European UDI workaround

  • EU-MDR database elements

  • EU-IVDR database elements

  • Database translation issues


BONUS: Attendees will receive an Excel workbook to help identify the database elements and verify the requirements.

UDI compliance includes data elements, verifying correctness and update labels and translating and loading the database. Success demands a team effort. Take this opportunity to bring every member of the team up to speed.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally

to learn about our special multisite discount.

Webinar Details:

Understanding UDI in EU Device Regulations

An FDAnews Webinar

Thursday, Nov. 21, 2019, 1:30 p.m. – 3:00 p.m. EST

https://www.fdanews.com/understandudi

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/understandudi

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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