Medical devices (ISO 10993)

Toxicology Knowledge Team has extensive experience in the field of Medical Devices and the Guidance Standards ISO 10993. Do not hesitate contacting TKT for further discussions on how TKT can provide the right support. We offer e.g. the following services.

  • Toxicological investigations / advice / classification / risk assessment of medical devices within the ISO 10993 standards.
  • Preparation of a Biocompatibility Test Plan / Biological Evaluation Plan.
  • Preparation of a Biological Evaluation Report.
  • Study design, outsourcing, monitoring and evaluation (including risk assessment) of studies at contract research organisations (CROs).
  • Genetic toxicity risk assessment, including in silico analysis, of extractables, leachables and degradation products.
  • Risk assessment of medical devices impurities, including polymers (plastic/silicon), solvents, metals and genotoxic impurities.
  • Literature reviews, e.g. as part of material characterisation, in accordance with ISO 10993: 2009 and ISO 10993: 2018
  • Customized external training on the ISO 10993 standards.
  • Literature and database searches according to customer specific requirements.
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