Celegence Webinar: How to Start Preparing Your Team for the EUDAMED Database

What: Webinar in coordination with Q1 Productions showing you how to take advantage of the EU MDR and EUDAMED delay
When: Sept. 22th 2020, 10:00am – 11.30am CT
Where: Online Event
How: Register online now
Why: You will learn how the implementation of EUDAMED affects your organization, and how the extra time should be leveraged by your RA/QA team.

With the European Commission delaying the implementation of EUDAMED, medical device companies now have an opportunity to be proactive. According to the EC, this new IT system aims to improve “transparency and coordination of information” for devices within the European marketplace. The way in which this system will impact your current RA and QA process varies in scope and depth. Though multiple modules will be rolled out in a phased approach, there will be significant changes on a few key areas such as UDI, notified body interactions, actors, post-market surveillance, and vigilance. 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 subject matter expert, John Bradsher.

Celegence will be hosting the WEBINAR in partnership with Q1 Productions on September 22nd, at 10am (CT). Register online now!

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 assignments he has managed the development of clinical evaluation documents for a global manufacturer, Bausch Health.

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.

• Explanations of various modules of EUDAMED – including the Single Registration Number module, and the UDI-DI module
• Explanation of UDI of various Therapeutic Areas and Product Types
• Interactions necessary between legal manufacturers and their economic operators
• Required clinical evaluation documentation with respect to CER/CEPs, as well as SSCP and the PMCF Plans
• Q/A with expert Panelists, including members of NBs

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

• Identify which areas of EUDAMED require relevant changes by your staff
• Identify which areas will necessitate a regulatory partner
• Have a broader understanding of the timeline regarding your staff’s updated processes in accordance with MDR
• Leave with a thorough understanding of the nuances of the EUDAMED modules

This webinar is perfect for and geared towards:

• Quality managers
• Regulatory managers
• Technical writers
• Operations managers
• Design managers
• Technical managers
• Clinical managers
• Authorized representatives in representatives in Europe

The How to Start Preparing Your RA/QA Team for the EUDAMED Database webinar will be held on September 22nd 2020 from 10-11.30am CT. Make sure you secure your seat at the webinar by registering now.

As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all 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 hope that you can join us then.