Handheld Brain Scanner

When a medical device company developing a Class II handheld diagnostic tool for our nation’s finest, needed expert support to meet FDA certification requirements, they turned to PSI for our deep experience in regulated software development (ISO 13485, IEC 62304, and cybersecurity). Their device uses Near-Infrared (NIR) technology to detect intracranial bleeds and traumatic brain injuries (TBI) — a high-stakes application that demands uncompromising reliability, precision, and regulatory compliance. PSI was brought in as the lead software consultant to evaluate the existing software systems and ensure alignment with FDA expectations.

Our team conducted a comprehensive review and overhaul of the device’s software documentation, aligning all artifacts — including design specifications, risk management files, and standard operating procedures (SOPs) — with FDA regulatory standards. PSI not only organized and enhanced the existing documentation but also created new artifacts where gaps existed, enabling the client to move confidently through the FDA submission process. Our regulatory expertise ensured that the software development lifecycle (SDLC) was traceable, testable, and fully auditable — key requirements for medical device approval.

On the development side, PSI re-engineered critical portions of the software to integrate with newly updated hardware, improving overall system performance and reliability. We designed and implemented a responsive, modern user interface using TouchGFX, providing a clean and intuitive experience for clinicians operating the device in high-pressure environments. Additional features and refinements were incorporated based on direct feedback from the client’s clinical advisors. The result: a powerful, compliant, and user-friendly medical device, supported by airtight documentation and robust software architecture, ready for market deployment.