All in One Software Solutions and Expert Consulting for Managing Medical Device and Drug Combination Product Risks: Safety, Regulatory, Cybersecurity, and Quality
Advance medical device and combination product risk management
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
Our vision is to provide a holistic all in one solution to streamline, automate, centralize and seamlessly connect your quality management systems, and intuitively comply with applicable regulatory requirements
GessNet TurboAC™ software provides all in one solutions for Total Product Life Cycle (TPLC) medical device risk management & assurance case in compliance with ISO 14971 and FDA requirements
The TurboAC™ software allows your organization to define your own "rules" on medical device risk management per ISO 14971, e.g. scales for severity and probability, acceptability matrix etc.
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.