Biological Evaluation of Medical Devices According to ISO 10993-1 and FDA Guidance, Present and Future Trends

The web-seminar takes place in 2 training units on 2 consecutive days including breaks.

Embark on a comprehensive exploration of biological evaluation for medical devices in this training course. Covering regulatory standards like ISO 10993 series and FDA guidance, learn to conduct detailed evaluations for diverse medical devices. Explore updates from ISO TC194, craft biological evaluation plans, and understand extractable leachables testing, biological testing methodologies, and toxicological characterization. Gain insights into selecting testing labs, handling failures, and nuances around CMR, ED substances, and nanoparticles. Discover integration strategies for biological evaluations into your Quality Management Systems (QMS). This course provides both theoretical knowledge and practical insights, empowering participants to execute thorough and compliant evaluations efficiently.

Your benefit

By completing this course, you'll gain comprehensive expertise in conducting biological evaluations, enabling confident navigation of regulatory standards and methodologies. Equip yourself with the practical skills needed to ensure the safety and compliance of medical devices, enhancing your professional capabilities.



  • Regulatory overview: ISO 10993 series, FDA guidance, and conducting detailed evaluations for various medical devices.

  • Essential aspects covered: Updates from ISO TC194, crafting biological evaluation plans, extractable leachables testing, biological testing methodologies, and toxicological characterization.

  • Practical considerations: Selecting testing labs, strategies for handling failures, and understanding CMR, ED substances, and nanoparticles.

  • Integration with QMS: Strategies to seamlessly integrate biological evaluations into Quality Management Systems for compliance and efficiency.


Target audience
Manufactures of Medical Devices (quality management, regulatory affairs, research and development, toxicologist)
Language of training material
Basic knowledge of the medical device industry.