Advance medical device and combination product risk management
ISO 14971 risk management and assurance case software

TurboAC™ Risk Management Software

Streamline, automate, and improve medical product risk management & assurance cases to make safety, cybersecurity, quality, regulatory compliance, and productivity a competitive advantage

Dr. Andrei Yosef, VP of Q Core Medical sharing their experience with the TurboAC™ software. Q Core has received FDA's clearance for its Sapphire infusion pump system using TurboAC™ software  - News Release


TurboAC™ Risk Management Software

All in one solution to streamline and automate risk management process:  risk ranking, Fault Tree Analysis (FTA), FMEA, tracing to requirements and testing, Total Product Life Cycle (TPLC) management, and intuitive compliance with ISO 14971

TurboAC™ Assurance Case Software

Software tool for safety assurance
case development and integration with
risk management: graphic, tabular and narrative format assurance case reports, and electronic submissions to FDA

TurboAC™ Evidence (Supporting Document) Management Software

Software utility to centralize and manage risk traceability supporting information such as risk benefit analysis, requirements, test cases, SOPs, CAPAs, Complaints, Product failure codes etc.