Biocompatibility testing shows that the materials in your device do not cause harmful reactions when they contact the body.
The tests required depend on the type and duration of contact, for example skin contact for minutes versus an implant left in place for years.
Choosing materials with an established safety history can simplify testing. Changing a material late in development may mean repeating tests.
Plan biocompatibility alongside your design decisions, and keep clear records of every material and supplier.
