OPERATING ROOM INJECTABLE POLYMER SYSTEM
This Class III hand-held medical device contains a real-time embedded microprocessor that heats a biodegradable polymer compound to a specified temperature, allowing the doctor to rapidly reassemble severely shattered bones within minutes. The firmware provides unique features to heat and form the proper bond points, ultimately attaching to bone fragments. Development was to FDA 21 CFR Part 11 and 21 CFR Part 820 compliance, ISO 13485 and ISO 9001 standards, and Object-Oriented Programming concepts.
How PSI Helped:
- Medical Device Software System Design
- Medical Device Software System Development
- Medical Device Software System Testing
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