Head Injury Assessment Tool

MILITARY HEAD INJURY ASSESSMENT TOOL

This Class II handheld, portable medical device is used by the United States Marine Crops and United States Army head to quickly triage war fighters in the field for intracranial bleeds through Near-Infrared (NIR) technology. PSI served as a software engineering consultant as well as prime software developer to help the client prepare for FDA submission.

How PSI Helped:

• Provided consulting services for deep knowledge of medical device regulatory and documentation requirements surrounding 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and more.
  • Performed gap analysis to determine missing software regulatory components ahead of submission
• Developed new documentation and remediated client’s existing documentation as necessary, including Standard Operating Procedures (SOPs), design documentation, risk management documents, and other miscellaneous procedures and protocols.
• Software Development
  • Code clean up and remediation from the engineering firm that previously worked on the project.
  • Development and implementation of new features
  • Refactored software to seamlessly work with new hardware component
• Software Testing
  • Software Verification
  • Unit Testing
  • Static Analysis

Continue here to learn more about military software development.

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