Positive Risk-Benefit Ratio: Compliance at the Intersection of Clinical Practice and Risk
Clinical evaluation and risk management are among the core requirements of the MDR and together form the foundation for the safety and performance of medical devices.
Both disciplines are closely interlinked: Clinical evaluation and risk management can no longer be viewed as isolated processes. The MDR requires a consistent integration here: Clinical data validates the theoretical assumptions of risk analysis, while risk management helps determine the focus of clinical data collection.This interface forms the foundation of robust technical documentation and is crucial for your product’s marketability.
In practice, this interface poses challenges for many companies. Different perspectives, documentation requirements, and regulatory expectations must be reconciled in a manner that stands up to audits. This is precisely where this seminar comesin.
We provide you with a deep understanding of the interplay between clinical evaluation and risk managementin accordance withthe MDR, as well as the relevant standards and guidelines. You will learn how clinical data and risk management are interconnected and how both processes interact efficiently and sustainably.
The goal of this seminar is to provide you with practical strategies and methods for consistently and compliantly integrating clinical evidence and risk assessment into the product lifecycle.
- Content
- Interface Analysis: Clinical Evaluation and Risk Management according to MDR and ISO 14971
- The Role of Clinical Data in identifying and assessing Risks
- Deriving Clinical Risks from Literature, PMCF, and Post-Market Data
- Integrating Clinical Evidence into Risk Analysis and Risk Assessment
- Benefit-Risk Analysis as a link between Clinical Evaluation and overall Residual Risk Assessment
- Use of Post-Market Surveillance and PMCF Data to update Risk Management and Clinical Evaluation
- Consistent Documentation Between Clinical Evaluation and Risk Management File
- Typical Weaknesses and Expectations of Notified Bodies
- Your Benefits
- You will gain a thorough understanding of the regulatory requirements for clinical evaluation and risk management under the MDR.
- You will learn how clinical data and risk analysis are interrelated and how to conduct a benefit-risk assessment.
- You will learn how to ensure consistency between clinical evaluation, PMS, PMCF, and risk management.
- You will gain practical approaches to avoiding typical audit and NB objections at this interface
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Clinical Affairs Managers
- Risk Management Experts
- Regulatory Affairs Managers
- Medical Device Manufacturers
- Developers and Project Managers in the Medical Technology Sector
