Learn how to align chemical testing with biological risk management and create a stronger evidence foundation for regulatory readiness.
Chemical characterisation is no longer simply a laboratory task completed after key development decisions. ISO 10993-1:2025 places it at the foundation of biological evaluation, making closer alignment between test data, toxicological assessment and submission evidence increasingly important.
Join this webinar to learn how ISO 10993-18:2020 connects with ISO 10993-1:2025. Our experts will discuss regulatory expectations, common evidence gaps and general approaches for manufacturers and laboratories to work together.
Join this webinar to learn how ISO 10993-18:2020 connects with ISO 10993-1:2025. Our experts will discuss regulatory expectations, common evidence gaps and general approaches for manufacturers and laboratories to work together.
What you will learn
- Building a strong ISO 10993 strategy
See how ISO 10993-18:2020 connects with the risk-based biological evaluation framework established in ISO 10993-1:2025. - Meeting regulatory needs
Learn how stronger alignment between test data, toxicological assessment and submission evidence can support regulatory readiness. - Working with laboratories
Find out how manufacturers and laboratories can align earlier to reduce avoidable questions, repeat work and project uncertainty.
Who should attend
This webinar is intended for medical device professionals involved in biological evaluation, chemical testing, product safety and regulatory submissions.
- Medical device manufacturers
- Regulatory affairs professionals
- Biological safety and toxicology specialists
- Research and development teams
- Quality and product compliance professionals
Meet the speakers
Dr Christoph D. Lindner
Team Leader for Chemical Testing and Biocompatibility, TÜV SÜD
Rachele Nardella
Sales Manager, Medical Health Service Department, TÜV SÜD
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