Risk-based test protocol development confirming device outputs meet design inputs, with statistical rationale for sample sizes, acceptance criteria, and edge case scenarios that satisfy FDA/Notified Body scrutiny.

ISO 10993 biological evaluation plans and sterilization validation (EtO, gamma, e-beam) aligned with patient contact duration and tissue exposure, preventing costly re-testing from incomplete initial protocols.

Dose accuracy, container closure integrity, extractables/leachables, and delivery performance testing for prefilled syringes, autoinjectors, and infusion pumps.