Toxicology Knowledge Team

Medical Devices

  • 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.