Advanced Biocompatibility - Risk Assessment of Migrating Substances
The participants will achieve an understanding of how to perform a comprehensive toxicological risk assessment of migrating substances in accordance with the latest regulatory requirements including MDR/IVDR and guidance in relevant standards ISO 10993-1, ISO 10993-17, ISO 10993-18.
The participants will achieve an understanding of how to perform a comprehensive toxicological risk assessment of migrating substances in accordance to latest regulatory requirements including compliance documentation in MDR/IVDR and ISO 10993-1, ISO 10993-17, ISO 10993-18 standards. A thorough walk through chemical characterization of migrating substances and practical application of toxicological risk assessment during design and development phase will be presented.
Comprehensive risk assessment of migrating substances has become increasingly important for the medical device industry. During the course participants will learn about the risk assessment tools and methods including safety assessment of a medical device. New regulation and standards for chemical characterization of migrating substances and risk assessments will be covered. Practical implementation of the requirements will be presented and discussed.
The course consists of 2 two days, however, it is possible to register just one day.
Who should attend
This course is targeted at but not limited to:
- Product design engineers
- Biosafety specialist
- Material specialist
- Risk managers
- Regulatory specialist and manager
DHI, Environmental and Toxicology
Poul Bo Larsen, Chief Toxicologist
Brian Svend Nielsen, Senior Toxicologist, ERT