Taking Advantage of the EU MDR Delay in Uncertain Times – Webinar
Overview
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The Art of Benefit-Risk Calculation – Essential Tools for EU MDR Mastery
Join us for an engaging discussion where medical device regulatory subject matter experts will explore tools and strategies to streamline benefit-risk calculations under the EU MDR framework.
This webinar will provide practical guidance on calculating both qualitative and quantitative benefit-risk profiles, helping you avoid non-conformances and deliver compliant, data-driven submissions.
Through real-world case studies, our experts will demonstrate how to streamline the assessment process and present measurable outcomes that stand up to regulatory scrutiny. Whether you’re involved in regulatory submissions or product development, this session will give you the tools you need to navigate the EU MDR’s rigorous benefit-risk requirements.
Don’t miss this opportunity to enhance your regulatory skills and understanding.
What You Will Learn
Gain actionable knowledge and insights with our webinar:
- Understand the Benefit-Risk Framework: Explore how the EU MDR defines and evaluates benefit-risk balance
- Real-World Case Studies: Learn from industry case studies to understand common pitfalls and best practices for compliance.
- Prevent Non-Conformances: Avoid major non-conformances in benefit-risk documentation through effective strategies.
- Qualitative vs. Quantitative Assessments: Determine when to use qualitative versus quantitative assessments and how to present both effectively.
- Streamline Benefit-Risk Calculations: Apply tools and techniques that simplify the process of quantifying benefit-risk data for regulatory approval.
- Ensure Compliance with Notified Bodies: Discover how to meet the expectations of Notified Bodies for faster regulatory approval.
Webinar Speakers
Senior Manager, Medical Device Services, Celegence
Smridula Hariharan
team Lead, Medical Device Services, Celegence
Rohan Sathe
Authored By
Celegence Admin
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25 Apr, 2025
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