Overview
The Treatment Planning System (TPS) is clinical software designed to support radiotherapy workflows, enabling clinicians to define, optimize, and document treatment parameters prior to delivery. Software in this class is subject to IEC 62304 lifecycle requirements and must integrate tightly with device hardware and clinical data stores.
Role
Product and regulatory strategy for the TPS at Sensus Healthcare ensured that software development processes aligned with IEC 62304 requirements and that the system supported a defensible regulatory position.
TODO(nick): confirm whether AI/algorithmic planning is involved (if so add AI pillar), plus scope and outcomes.
Clinical SoftwareIEC 62304SQL