Understand how toxicological risk assessment supports safer, more efficient medical device development.
Medical device manufacturers face growing pressure to demonstrate biological safety under evolving international standards while managing complex analytical data, regulatory scrutiny and development timelines. Interpreting extractables, leachables and volatile organic substances in a consistent, science-based way is now essential to support compliance and reduce uncertainty.
In this white paper, we explain how chemical characterization and toxicological risk assessment support biological evaluation under ISO 10993-17:2023 and the ISO 18562 series. We outline the key concepts, thresholds and assessment approaches that help you translate data into clear safety.
What you will find in our white paper?
- The role of TRA in biological evaluationUnderstand how chemical characterization and toxicological risk assessment fit within the broader evaluation of medical device safety and compliance.
- Key concepts behind ISO 10993-17:2023Explore the principles of TQmax, TSL, EED and margin of safety, and how they support structured toxicological decision-making.
- Assessment of breathing gas pathway devicesLearn how volatile organic substances and leachables are evaluated under the updated ISO 18562 standards for breathing gas pathway applications.
- Practical value of a structured assessment strategySee how a consistent, risk-based approach can reduce unnecessary biological testing, improve assessment efficiency and support regulatory submissions.