The Art of Benefit-Risk Calculation – Essential Tools for EU MDR Mastery

When: Tuesday, October 29, 2024 | 10:00 AM – 11:00 AM ET (US)

Where: Online Event

How: Register Here

The complexities of EU MDR continue to challenge medical device companies, particularly when it comes to calculating benefit-risk profiles. These calculations are crucial for regulatory compliance, and mastering this process is essential for securing Notified Body approval. Celegence, in partnership with MedTech Intelligence (MTI), invites you to attend a focused webinar where we will explore tools and strategies to streamline benefit-risk calculations under the EU MDR framework.

Benefit-risk assessments are a cornerstone of ensuring that medical devices are safe and effective for their intended use. However, preparing accurate, thorough documentation that meets Notified Body expectations can be a significant challenge. 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.

• 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.

• Smridula Hariharan, Senior Manager, Celegence: With over 12 years of medical writing experience, Smridula has extensive knowledge across medical devices and in-vitro diagnostics. She has successfully facilitated CE marking under MDD and MDR for both legacy and innovative products and has developed SOPs and templates for essential MDR/IVDR documents such as CEPs, CERs, SVRs, and PMCF reports.

• Rohan Sathe, Team Lead, Celegence: Rohan brings over 9 years of expertise in clinical evaluations, Post Market Surveillance (PMS), and Software as a Medical Device (SaMD). His leadership in managing cross-functional teams and resolving Notified Body observations has ensured successful medical device compliance across various device classes.

This webinar is designed for professionals involved in medical device regulatory submissions, product development, clinical evaluations, and compliance. Whether you are part of a regulatory affairs, quality assurance, or clinical affairs team, this session will equip you with essential tools to navigate EU MDR’s benefit-risk assessment requirements.

Don’t miss this opportunity to deepen your understanding of benefit-risk calculations and ensure your organization’s regulatory readiness. Register Here to join industry leaders in discussing best practices for EU MDR compliance.

Celegence offers the expertise and technology to help organizations navigate regulatory compliance challenges. As a global leader in regulatory solutions, Celegence supports compliance with EU MDR and IVDR through services like gap analysis, PMS reporting, clinical documentation, and Notified Body interactions, all designed to enhance efficiency and save time. Our innovative CAPTIS™ platform boosts medical writing efficiency, ensures ongoing compliance, and adapts to evolving regulatory needs, empowering organizations to achieve success in the medical device and IVD sectors.

For more information on how we can help you with EU MDR and IVDR requirements reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.