A medical device company developing a portable ultrasonic energy system for soft tissue removal during surgery.
Redesign and extend the software control system for a prototype ultrasonic surgery device, ensuring it meets FDA regulatory compliance requirements and is ready for production.
The client had a working prototype but lacked a compliant, production-ready software system. Key technical requirements included:
Hardware control capability
Analog data acquisition
Timing resources
Data logging
Remote communication and data transfer
User interface support
Hardware error detection with redundancy
FDA software documentation
Integration into the production model
Impact ES–Rhode Island developed firmware using its proprietary, royalty-free kernel based on finite state machine architecture. Written in C for performance and maintainability, the design resulted in a compact, testable code base. Impact ES also delivered comprehensive documentation for:
Requirements
Software architectural design
Verification testing
This documentation supported the client’s FDA 510(k) submission.
A fully integrated, FDA-compliant software control system, ready for production and regulatory approval.
A strong architecture (finite state machine) supported speed and maintainability
Custom kernel eliminated licensing concerns
Comprehensive documentation was essential for regulatory approval
Integration of software into the final production model ensured a smooth transition from prototype to product
