Missed our live session? Access the full recording now and discover how real-world evidence (RWE) and post-market clinical follow-up (PMCF) are revolutionizing cardiovascular device development under the Medical Device Regulation (MDR).
What You'll Learn
This comprehensive webinar brings together three leading experts who share critical insights on implementing RWE strategies for cardiovascular devices:
Dr. Yu Jin
SGS, Cardiologist & Notified Body Expert
Discover what notified bodies expect when reviewing cardiovascular devices that leverage real-world evidence for MDR compliance.
Dr. Matthias Fink
AKRA TEAM, Orthopaedic Surgeon & Senior Consultant
Gain a consultancy perspective on building robust, MDR-ready RWE strategies that meet regulatory requirements.
Dr. Nikhil Khadabadi
Eclevar MedTech / Milo Healthcare, CMO
Learn practical, actionable approaches to capturing, curating, and utilizing real-world evidence for cardiac devices.
Key Topics Covered
RWE Strategy for Cardiovascular Devices
How to design and implement real-world evidence strategies that meet MDR requirements and notified body expectations.
PMCF Best Practices
Practical approaches to post-market clinical follow-up that generate robust, scientifically valid data for cardiac devices.
Regulatory Compliance & Notified Body Review
Insider insights on what notified bodies look for when evaluating RWE data and PMCF strategies.
Real-World Data Collection & Analysis
Methodologies for capturing, curating, and analyzing real-world data to support cardiovascular device development.
Who Should Watch This
Cardiovascular device manufacturers seeking to implement robust RWE strategies for MDR compliance.
Regulatory affairs professionals designing PMCF studies for cardiac devices.
Clinical research teams preparing for notified body submissions with real-world evidence.
Quality and compliance managers navigating EU MDR requirements for cardiovascular products.
