All-in-one Software Solution and Expert Consulting for Medical Device and Drug Combination Product Design Controls, Risk Management, Cybersecurity, and Safety Assurance Cases
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
Proudly served for more than 35 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.