June 5, 2024 | Hyatt Centric Downtown Minneapolis

MedTech Event: EU MDR Regulatory Updates and Best Practices for Evidence Management

Agenda – June 5, 2024

12:00 pm – 1:00 pm CDT

Lunch + Registration

Status of EU MDR 2017/745 and Key Learnings from initial EU MDR Certification

Dr. Bassil Akra, Founder and CEO at AKRA Team GmbH
Rita Guzzetta, VP of Regulatory & Technical Communications at Medtronic
Dr. Matthias Fink, Senior Clinical Consultant at AKRA Team GmbH

NB Update: Clinical Evaluation Assessment Process

Richard Holborow, Global Head of Clinical Compliance at BSI Notified Body (NL) & BSI Approved Body (UK)
Gretchen Adams, Technical Director at DEKRA Product Testing & Certification
Nunung Nur Rahmah, Head of Internal Clinical Team at DEKRA Product Testing & Certification

Integrating AI for Regulatory-Compliant Literature Reviews: Trends & Forecast

Peter O’Blenis, CEO at DistillerSR

Best Practices for RWE in EU and US Markets

Amelia Hufford, Co-founder and SVP, Clinical and Regulatory Science Operations at 3Aware

Wendy Pierce, Phd, Senior Clinical Research Program Manager, Peripheral Vascular Health at Medtronic

Best Practices for Enterprise Evidence Management

Peter O’Blenis, CEO at DistillerSR
Emily Metcalfe, Director, Scientific Communications at Boston Scientific
Dr. Matthew Cooper, CEO at Peak Cardiovascular

5:30 pm – 6:30 pm CDT

Networking hour

Why You Should Attend

Understand the current status, key provisions, and timelines of the EU MDR, and how to develop a strong strategy for compliance and market readiness.

Learn about the latest updates from the Medical Device Coordinating Group (MDCG) on clinical investigation guidance, including how these revisions impact the planning and conduct of clinical trials.

Gain clarity on notified body’s expectations for clinical evaluation requirements under the EU MDR, including methodologies for assessing clinical data and demonstrating device safety and performance.

Hear firsthand experiences, key lessons, and practical insights from organizations that have successfully navigated the initial EU MDR certification process.

Explore effective strategies for conducting literature searches and appraising relevant clinical data for EU MDR clinical evaluation requirements.

Assess the transformative role of AI in conducting literature reviews that adhere to regulatory standards.

Discover how RWE can be leveraged to support clinical claims, including the nuances and best practices for RWE utilization across the US and the EU markets.

Register Now