NEW!

The NextGen QMS Software Solutions

To integrate, streamline, and simplify medical device and combination product design controls, risk management based on the industry best practices, and 

 

make product safety, effectiveness, time to market, cost of maintenance, compliance and quality a competitive advantage

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Proudly served for more than 30 Medical Device / Pharma Companies such as ...

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.