Planning and preparation of biocompatibility evaluations

Your partner for biocompatibility, inmedis Zug

Titanium - ceramic – polymers – cytotoxicity – sensitization – irritation – biological endpoint - does your product meet the latest requirements regarding biocompatibility?

The ISO 10993 series of standards as well as the FDA guidance “Biological evaluation of medical devices” increasingly call for a risk-based approach. In particular, the new ISO 10993-18 sets the bar even higher with regard to test methods and chemical characterization of materials.

We support you with the following services - so that biocompatibility does not become an emotive term for you or for your customers:

  • Conduct internal trainings
  • Update of your procedures to the latest requirements
  • Gap analysis of existing biocompatibility records
  • Creation of risk-based test plans
  • Coordination of tests with qualified test laboratories
  • Evaluation of the test results and creation of the reports

Felix Mauch, CEO, P. & A. Mauch

„Good news: our Notified Body has accepted the biocompatibility report. With great thanks and respect for the excellent work!"