Advance your Medical Product Safety Engineering
All-in-one best practice based software solution / Expert consulting for design controls, risk management, cybersecurity, and safety assurance cases in compliance with the standards and regulations
The Next-Gen QMS Software Solution
Streamline medical device and drug device combination product design controls, risk management, cybersecurity, and safety assurance case development.
Provide an end-to-end complete solution for assuring safety and effectiveness throughout the product life cycle with out of box templates based on the industry best practices.
Digitalize product and quality system documentation, and build the foundation for an AL powered QMS.
A distinguished tool for building a competitive advantage on safety, quality, compliance, time-to-market, and costs of maintenance.
Risk Management Software
TurboAC™ Assurance Case Software
TurboAC™ Evidence (Supporting Document) Management Software
All-in-one solution to streamline and automate the 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
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
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.