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
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.
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
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.