Being equipped with all you need risk analysis tools, GessNet’s TurboAC™ automates, streamlines safety and cybersecurity risk management activities, maintains records and results throughout the product life cycle. It makes it easy for manufacturers to adhere to industry standards (e.g. ISO 14971) and FDA requirements, and integrates safety assurance case method into the risk management process as needed. With TurboAC, multiple processes, including hazard analysis, security threat and vulnerability analysis, fault tree analysis, attack tree threat modeling, failure mode and effect analysis, safety and security risk assessments, assurance case development, post market product risk vigilance and risk management file maintenance, can all be performed jointly in one electronic system throughout a product life cycle. Also, the risk information can be analyzed and reported in multiple formats to suit various needs. “Based on engineering science for safety, TurboAC is specifically designed for medical product risk management, and is highly flexible and configurable for generating various reports to meet various regulatory compliance or business practice needs,” remarks Fubin Wu, Co-Founder. In addition, the company’s risk management consultants help manufacturers gain the latest insights for staying ahead of the curve in industry’s best practices for safety, regulatory compliance, time to market, and engineering productivity.
Based on engineering science for safety, TurboAC™ is specifically designed for medical product risk management, and is highly flexible and configurable for generating various reports to meet various regulatory compliance or business practice needs
Having served many manufacturers over the years, GessNet’s mission has always been to advance medical product risk management and make it a competitive advantage for the clients. Moving forward, the firm plans to build on their mission. Wu reckons that risk management is the central intelligence unit for medical product manufacturers to implement risk driven quality and business management systems, and risk management should be connected to any safety related systems or information intelligence centers to comprehensively manage risk. “Our future releases will continue expanding TurboAC’s connectivity to other electronic systems or information centers,” concludes Wu.