Expert-level competency in the tools and processes used across the design control lifecycle, including requirements development and decomposition, traceability, risk management, verification and validation planning and execution, test method development and validation, statistical techniques and sampling rationale, design review leadership, and Design History File construction. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women's health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.