Surgical Robotic System
A novel Class III medical device with 5 software sub-systems designed by PSI

A promising surgical robotics start-up with a bold vision to revolutionize endoscopic procedures turned to PSI to help bring their innovative concept to life. Initially engaged as a software consultant, PSI rapidly became the client’s lead software design and development partner, entrusted with building the foundation of a next-generation robotic surgery system. With a shared commitment to advancing surgical precision and patient outcomes, PSI collaborated closely with the client’s engineering team to transform conceptual ideas into functional, compliant, and scalable software systems.
PSI led the architecture and development of several core subsystems, including a highly intuitive user interface, precision motion control logic, and a robust safety supervisor to ensure surgical integrity under all conditions. We also designed and implemented a PC-based support tool to assist with system configuration, diagnostics, and real-time monitoring — critical tools for surgeons and support staff in operating room environments. Throughout the process, our team emphasized modularity, real-time performance, and fault tolerance, all aligned with the stringent quality and safety standards (ISO 13485 and IEC 62304) required in the medical device industry.
The result is a cutting-edge surgical robotic platform offering exceptional dexterity, precision, and control, pushing the boundaries of what’s possible in minimally invasive surgery. By integrating sophisticated software systems with advanced mechanical design, PSI helped the client accelerate development timelines, de-risk critical technical components, and position their technology for future regulatory submissions (De Novo pathway) and clinical use. Our partnership empowered the start-up to move from concept to functional prototype, paving the way toward commercialization and improved surgical outcomes.
Quick Facts
PSI’s Role: Software Consultant, System Architect, Software Design, Software Development
- Device Classification: Class III
- Submission Type: De Novo
- Software Type: Embedded System