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
Prepare Now for the EUDAMED UDI/Registration Module
March 15, 2021, 04:00 PM
John Lorenc & Gary Saner
Reed Tech & Reed Tech
Implementing and Maintaining Changes to SaMD Under MDR
March 18, 2021, 02:00 PM
Magdalena Kocot
Regulatory Project Manager, ICS
Addressing the Notified Body Bottleneck
March 19, 2021, 02:00 PM
Eric Henry
Sr. Quality Systems & Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
March 16, 2021, 03:00 PM
Carolyn Guthrie
Director of QA/RA, Kapstone Medical
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
Sessions From World-Class Medical Device Leaders
We couldn't be more excited about our lineup. Which sessions will you be checking out?
