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Whether you've fully transitioned, are just getting started, or are planning to enter the EU market in the future, you won't want to miss this free virtual summit that covers common questions, pitfalls and strategies for operationalizing the requirements, and how to apply best practices to ensure ongoing compliance.


WHAT TO EXPECT AT THE EU MDR & IVDR TRUE QUALITY SUMMIT SERIES

The European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/ IVDR) should make for a healthier medical device landscape in the EU once implemented.

But, as we rapidly approach the deadlines, how can companies prepare and set themselves up for ongoing success in the years to come?

The week long, online EU MDR & IVDR Virtual Summit will help quality, regulatory and product development professionals understand the new EU medical device regulations and strategic ways for companies to be both successful and competitive in the European market once MDR and IVDR go into effect.

The EU MDR & IVDR Virtual Summit is for you if you are looking to:

• Meet compliance requirements of EU MDR and IVDR before deadlines and maintain ongoing compliance

• Simplify the process of finding a Notified Body and understand how they will conduct audits under new regulations

• Meet new technical documentation requirements

• Learn and apply the new scope of new economic operator requirements


• Comply with stricter clinical evaluation and post-market surveillance requirements while demonstrating total life cycle traceability

• Understand Brexit impact and how to capitalize on a new UK market

•  Discover new ways to foster collaboration and promote innovation to streamline transition planning, execution and continued compliance

Proudly supported by

How to Meet Cybersecurity Requirements of EU MDR & IVDR March 18, 2021, 04:00 PM
Justin Heyl NA Program Manager, Cybersecurity, Digital and AI in Lifesciences, TÜV SÜD
Understanding Device Classification and Other Significant Changes Under IVDR March 17, 2021, 01:00 PM
Andrew Frink Regulatory Affairs Manager, Proxima Clinical Research
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process March 15, 2021, 01:00 PM
Jon Speer Greenlight Guru, Founder
The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification March 19, 2021, 01:00 PM
Ronald Boumans Senior Consultant, Regulatory Affairs, Emergo by UL

This True Quality Summit Series is Highly Recommended For:

• Medical Device Executives & Leadership Teams

• Quality Professionals and Management

• Regulatory Affairs Professionals and Management

• Clinical Affairs Professionals and Management

• R&D Engineers and Management