March 15-19, 2021

EU MDR & IVDR True Quality Summit Series

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.

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.


Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process | Jon Speer

How to Maintain a QMS Compliant to MDR & IVDR | Kyle Rose

MDR with Brexit: How the Combination is Impacting the European Medical Device Industry | Thor Rollins

Prepare Now for the EUDAMED UDI/Registration Module | John Lorenc and Gary Saner

Economic Operators: Implementation Challenges and Opportunities | Hilde Viroux

Essentials for Clinical Evaluation of Medical Devices | Michael Brillhart and Patti Rossman

CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR | Carolyn Guthrie

Effective Post-market Surveillance in the EU under MDR | Isabella Schmitt

How to Create Medical Device Labels per EU MDR | Monir El Azzouzi

Risk Management According to EU MDR or ISO 14971? | Peter Sebelius

Supply Chain Management under the MDR, Brexit and Swixit | René Van De Zande

How to Prepare for Common MDR Audit Pitfalls | Bassil Akra

Implementing and Maintaining Changes to SaMD Under MDR | Magdalena Kocot

The Who, What, and When of IVDR Enforcement | Joanne Lebrun

How to Meet Cybersecurity Requirements of EU MDR & IVDR | Justin Heyl

The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification | Ronald Boumans

Addressing the Notified Body Bottleneck | Eric Henry

From Self-Declaration to Certification: Proving Performance Under IVDR | Joanne Lebrun

The New MDR: Is it Really New and Do We Really Need It? | Michael Drues

Watch the Summit Series

EU MDR & IVDR Virtual Summit Series - Press Release Graphic
Specifically, this summit series will cover:
  • 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
Who should attend? 
  • Medical Device Executives & Leadership Teams
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management
Register Now  

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