Handheld Brain Scanner

This Class II handheld, portable medical device scans a patient’s head to detect intracranial bleeds and Traumatic Brain Injuries (TBI) through Near-Infrared (NIR) technology. PSI served as the lead software consultant and software engineering firm to help the client address FDA certification concerns. PSI reviewed, organized, and created documentation to address FDA software regulatory requirements using the client’s Standard Operating Procedures (SOP), design documents, risk management documents and other miscellaneous procedures and protocols. From a software development standpoint, PSI re-engineered much of the existing functionality to work with newly designed hardware, implemented a complete Graphical User Interface (GUI) using TouchGFX, and incorporated additional functionality as directly requested by the client.