Webinar: Biocompatibility in practice

Biocompatibility planning is a critical part of medical device development, particularly for devices with direct or indirect body contact. As expectations around biological evaluation continue to evolve, manufacturers are increasingly expected to apply a risk-based, scientifically justified approach that considers material composition, device contact, exposure duration and available supporting evidence.

This webinar provides an overview of how Chemical Characterization (CC), Toxicological Risk Assessment (TRA) and the Biological Evaluation Plan (BEP) can work together to support a structured biological evaluation strategy. Through practical considerations, participants will gain insights into planning evaluations more effectively, identifying common documentation gaps and aligning testing decisions with risk management principles.

•  Key considerations for biological evaluation under the ISO 10993 series.
• Understand how a risk-based biological evaluation approach can support more informed planning and decision-making.
• Learn how CC, TRA and BEP work together within a risk-based approach.
• Identify common gaps that may arise in biological evaluation documentation and how to address them proactively.

• Medical Device Manufacturers
• Regulatory Affairs Professionals
• R&D Engineers
• Quality Assurance / Quality Control Professionals
• Product Safety & Compliance Specialists

Biological Evaluation under ISO 10993

• Why a risk-based approach is becoming the industry expectation
• Key considerations for biological safety evaluation

Building the Biological Evaluation Strategy

• Role of Chemical Characterization (CC)
• Role of Toxicological Risk Assessment (TRA)
• Role of Biological Evaluation Plan (BEP)
• How these elements work together to support regulatory compliance

Common Challenges and Practical Considerations

• Potential pitfalls in biological risk assessment
• Avoiding unnecessary testing through proper planning
• Best practices for biological evaluations.

Case Study

• Practical example demonstrating the biological evaluation workflow

Q&A