- Toxicological investigations / advice / classification / risk assessment of medical devices within the ISO 10993 standards.
- Design, monitoring and evaluation of studies at contract research organisations (CRO).
- Genetic toxicity risk assessment, including in silico analysis, of impurities in medical devices, e.g. extractables, leachables and degradation products.
- Risk assessment of impurities in medical devices, including solvents, metals, leechables / extractables and genotoxic impurities. Development of test strategies for qualification studies.
- Writing of the toxicology sections of the regulatory documentation.
- Customized external training on the ISO 10993 standards.
- Literature and database searches according to customer specific requirements.