displayName
Biocompatibility Testing Cycle
workflowKind
governance
triggerType
event-driven
typicalCadence
per-release
complexity
cross-team
description
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.