Missed our live session? Access the full recording now and discover how three leading experts approach real-world evidence (RWE) for orthopaedic devices under the Medical Device Regulation (MDR). Learn from regulatory, consultancy, and technology perspectives.
What You'll Learn
This comprehensive webinar brings together three leading experts who share critical insights on implementing RWE strategies for orthopaedic devices:
Dr. Langhit Kurar
TÜV SÜD, Senior Clinical Reviewer in Orthopaedics
Discover what notified bodies expect when reviewing orthopaedic devices that leverage real-world evidence for MDR compliance.
Dr. Matthias Fink
AKRA TEAM, Senior Consultant & Orthopaedic Surgeon
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 orthopaedic devices.
Key Topics Covered
RWE Strategy for Orthopaedic 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 orthopaedic 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 orthopaedic device development.
Who Should Watch This
Orthopaedic device manufacturers seeking to implement robust RWE strategies for MDR compliance.
Regulatory affairs professionals designing PMCF studies for orthopaedic devices.
Clinical research teams preparing for notified body submissions with real-world evidence.
Quality and compliance managers navigating EU MDR requirements for orthopaedic products.
About the Organizers
Eclevar MedTech
A specialized Contract Research Organization focused on medical devices and In Vitro Diagnostics (IVD). We provide comprehensive clinical trial management, medical writing, regulatory affairs, and PMCF support to help MedTech companies achieve MDR compliance.
Milo Healthcare
An AI-powered Electronic Data Capture (EDC) platform designed for clinical trials in medical devices. Milo enables seamless data collection, real-world evidence capture, and regulatory compliance for orthopaedic and other therapeutic areas.
Need Personalized RWE Guidance?
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