This session provides pragmatic guidance on how to establish risk and overall residual risk acceptability, and how to perform a clear, structured benefit-risk analysis.
This webinar is intended for professionals working in regulatory affairs, quality assurance, clinical affairs, and product development. Whether you’re preparing documentation for a CE marking, updating technical files, or refining your risk management process, this session will offer practical tools you can apply immediately.
During the webinar, we will equip participants with actionable and pragmatic insights to establish risk and overall risk acceptability and to perform a benefit-risk analysis.
Here’s what you’ll learn:
- Fundamentals of risk management in the context of medical devices
- Determining individual and overall residual risk acceptability
- Exploring methods for evaluating overall residual risk
- Identifying and defining clinical benefits
- Insight into using literature searches to update risk and benefit acceptability
- Conducting both quantitative and qualitative benefit-risk assessments
Whether you’re finalizing your technical documentation or refining your approach to benefit-risk analysis, this session will give you the clarity and practical direction you need. Join us to strengthen your process, support compliance, and ensure your device stands on a well-justified benefit-risk foundation.
- Date: May 6th
- Time: 16:00 – 16:45 CET
Speaker:
- Tiago Fortunato: With a background in tissue engineering and immunology, including pre-clinical development of vascular access grafts, he transitioned in 2021 to the role of R&D engineer of dialysis and apheresis devices at a medical device manufacturer. For the last 3 years, he has been focused in regulatory affairs as a consultant. He brings in risk management and regulatory strategy (EU and US) expertise, helping companies navigate product development and compliance.
Register now to secure your spot!
