HEAD INJURY ASSESSMENT TOOL

This Class II handheld, portable medical device scans a patient’s head to detect intracranial bleeds through Near-Infrared (NIR) technology. PSI held engineering and consulting responsibilities to help the client address FDA certification issues.

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.
• 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.
• Unit Testing
• Performed gap analysis
• Static Analysis
• Code clean up and remediation from the engineering firm that previously worked on the project.
• Software testing

Continue here to learn more about custom medical software development.

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