Biocompatibility Under the New ISO 10993-1: Practical Strategies and Case Studies
Gain comprehensive insights into the major changes introduced in the new ISO 10993-1:2025 and understand how these updates impact the biological evaluation of medical devices
Course objective and outcome
By attending this course, you will gain comprehensive insights into the major changes introduced in the new ISO 10993-1:2025 and understand how these updates impact the biological evaluation of medical devices. You will learn how to implement a risk-based approach, define acceptance criteria, and prepare robust Biological Evaluation Plans and Reports that meet global regulatory expectations.
Content
The course covers the following key topics:
- Overview of Key Changes in ISO 10993-1:2025
- New definitions and acronyms
- Integration of Risk Management Framework with ISO 14971
- Biological Evaluation Plan and Report
- Essential content and structure
- Material Selections and Design Considerations in product development
- Exposure duration and categorization of medical devices
- Exposure duration and its implications
- Practical implications for device classification
- Understand the new categories
- Reasonably foreseeable misuse
- How to address in risk assessment
- Risk Estimation and Acceptance criteria
- Setting scientifically sound thresholds
- Biological equivalence
- Strategies for justification and documentation
- Bioaccumulation and Long-term Risks
- Mechanisms, testing approaches, and regulatory expectations
- Life cycle management
- Continuous evaluation and post-market surveillance
- Testing strategies and challenges
- Updated testing strategies due to new categorization
- New testing requirements
- In vitro vs. in vivo considerations
- Global regulatory expectations for implementations
- Interactive Case Studies
- Re-categorization exercises
- Risk-based evaluation scenarios
The training format consists of presentations with interactive discussions and group discussions linked to case studies.
Who should attend
The course is relevant for:
- Experienced biocompatibility specialists and biosafety specialists
- Toxicologist working with medical devices
- Regulatory affairs managers
Trainers
Monica Grekula ERT, Sr Director Biocompatibility & Toxicology, Veranex
Rose-Marie Jenvert PhD, Sr Biocompatibility & Toxicology Manager, Veranex
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Berit Munkebo
Head of Development
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