Biocompatibility Testing Cycle overview

Manages the biocompatibility testing lifecycle for medical devices per ISO 10993 -- selecting appropriate biological evaluation endpoints based on device contact type and duration, coordinating cytotoxicity, sensitization, and irritation testing with accredited labs, reviewing extractable and leachable study protocols against material composition data, tracking testing status across the biological evaluation matrix, evaluating historical biocompatibility data for predicate device equivalence claims, and compiling biological evaluation reports for regulatory submission. Produces biological evaluation plan, test status tracker, and BER (Biological Evaluation Report). Excludes device design changes.