Medical Device Biocompatibility

Biocompatibility must be demonstrated before the CE marking can be granted. Assessment of biocompatibility is done by a toxicologist.

With MADE, your company can achieve a marketing licence for a medical device as fast as possible.

MADE helps you in your medical device development process through:

  • Planning and designing the test strategy (biocompatibility test strategy/risk assessment/biocompatibility plan and report according to ISO 10993-1)
  • Writing a biocompatibility report for CE mark application, written by a European Registered Toxicologist as required by ISO 10993-1
  • Helping with non-clinical efficacy studies (planning, performing and reporting)
  • Helping with biocompatibility tests (CRO management)
  • Project management