Best Practices for UDI Implementation and EUDAMED Submissions – Webinar

• What: Webinar in coordination with Q1 Productions examining the best practices for UDI implementation and EUDAMED submissions
• When: January 20^th 2020, 10:00 am – 11:00 am EST
• Where: Online Event
• How: Register online now
• Why: To understand the best practices for registering medical devices in all risk classes and to learn about the known challenges of UDI implementation at major medical device manufacturers.

The EU MDR (EU 2017/745) date of application, 26 May 2021, is quickly approaching, and if your 2021 distribution strategy involves marketing medical devices in the European Union, it is critical to have a plan for submitting UDI data in compliance with the EU MDR. With the EU MDR following the FDA’s lead in requiring a UDI, regulatory affairs teams must be ready to update many of their processes to be able to register their products in the EUDAMED database. Additionally, certain best practices should be followed for creating structured device registration and Unique Device Identification (UDI) data, as well as for implementing EU MDR compliant product labels in order to comply with the date of application (DoA) requirements.

Your RA/QA team needs a solidified plan of action for how you will address these expanded regulations. Join us to hear from the perspective of our medical device subject matter experts, John Bradsher and Sharma Pokkuluri.

John Bradsher is a RAPS Global Certified expert in Regulatory Affairs and Quality Assurance of Medical Devices for Celegence. He has a background in the EU MDR that is both broad and deep: he has managed the program for MDR compliance at a medium-sized manufacturer of vascular medical devices, and in other positions, he has managed the development of clinical evaluation documents for a global manufacturer, BauschHealth. He comes from a background that is strong in basic science and biotechnology in addition to his mastery of regulatory and quality.  He has cleared several 510(k)s and has worked on products in EU classes I-III in his 27 years of project management.

Sharma Pokkuluri is an accomplished, analytical, and highly organized QMS auditor and Regulatory Affairs Management professional with over 8 years of frontline experience successfully overseeing the drug pipeline and legal compliance of a leading CRO and ensuring stringent quality standards across diverse pharmaceutical research and market analysis.

• Explanations of the best practices for registering devices in all risk classes
• Explanations of the known challenges of UDI implementation at major medical device manufacturers and what you can do to address them
• Q/A with expert panelists

Upon conclusion of the program, you will be able to:

• Understand the best practices for creating, managing, and submitting EU device registration and UDI information
• Understand the importance of controlling the UDI data
• Learn about the timing and requirements of EUDAMED submissions as per the EU MDR

This webinar is perfect for and geared towards:

• Unique Device Identification (UDI) Team Members
• Product Labeling Team Members
• Quality Managers
• Regulatory Managers
• Technical Writers
• Operations and Design Managers
• Technical and Clinical Managers
• Authorized Representatives in Europe

The Best Practices for UDI Implementation and EUDAMED Submissions webinar will be held on January 20th, 2020 from 10:00am-11am EST. Make sure you secure your place at the webinar by registering now.

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all other aspects of established product maintenance, including submission management, publishing, and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy, and intelligence. We are happy to share our insights with you through the webinar, and we hope that you can join us then.