The Life Cycle Rises: Applying ISO 10993-1 End to End

The Life Cycle Rises: Applying ISO 10993-1 End to End

The Life Cycle Rises: Applying ISO 10993-1 End to End

The 2025 revision of ISO 10993-1 marks a pivotal evolution in the biological evaluation of medical devices. This webinar will guide participants through the new requirements, focusing on the integration of biocompatibility assessment with risk management (ISO 14971) and the formalization of the Biological Evaluation Plan (BEP) as a central regulatory document.

Biological evaluation is now recognized as a continuous, life cycle-driven process for medical devices. The latest revision requires that biocompatibility assessment is not a one-time event, but an integrated activity spanning every stage, from initial design and material selection, through manufacturing, clinical use, and post-market surveillance. This approach ensures that biological safety considerations are embedded throughout the device’s development and operational phases, supporting ongoing compliance and patient safety.

Participants will learn how to implement the BEP as a living document, ensuring that biological safety is systematically reviewed and updated in response to changes in design, production, or real-world use. The BEP serves as the foundation for documenting device categorization, hazard identification, acceptability criteria, and evaluation strategies, and it must be maintained and revised as new information becomes available or as the device undergoes modifications.

The session will highlight practical strategies for managing reasonably foreseeable misuse, leveraging post-market data, and maintaining compliance as devices evolve. Attendees will gain actionable insights into aligning biological evaluation with risk management, optimizing documentation, and supporting regulatory decisions throughout the entire device life cycle. The webinar will also address the expanded terminology introduced in the new standard, the concept of biological equivalence, and the role of New Approach Methodologies (NAMs) in reducing unnecessary testing and supporting ethical compliance.

Whether you are new to ISO 10993-1 or seeking to update your processes, this session will provide a comprehensive overview and practical guidance for robust and efficient biological evaluation across the full life cycle of medical devices.

Why attend?

• Learn how to integrate biological evaluation into your device’s risk management system, ensuring compliance and reducing regulatory risk.
• Gain a clear understanding of the major changes in ISO 10993-1:2025 and their practical implications.
• Discover how to implement the Biological Evaluation Plan (BEP) and manage documentation across the device life cycle.
• Explore strategies to minimize unnecessary testing and leverage New Approach Methodologies (NAMs) for ethical and efficient compliance.

Who should join?

• Regulatory affairs professionals and compliance managers in the medical device sector.
• R&D and quality assurance specialists responsible for device safety and documentation.
• Toxicologists, biocompatibility experts, and consultants.
• Manufacturers, project managers, and anyone involved in the design, testing, or post-market surveillance of medical devices.