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