Medical Device Safety & Biocompatibility

Biological safety testing for medical devices depends on classification and intended application – this determines the biocompatibility programme in line with the regulatory requirements – this is often ISO 10993 guidance which outlines the required biological evaluation required for assessing medical device safety.

Peritus can help clients in numerous ways to determine the safety and biocompatibility of their medical devices:

Determination of medical device classification and regulatory pathway advise

Medical device materials characterisation

Undertake toxicology risk/safety margin assessments as required

Compliance to regulatory requirements – gap analysis, reporting

Design, place and monitor essential studies