This is an important concept, Naveen. As FDA shifts the QSR to the new QMSR and incorporation of ISO 13485:2016, manufacturers will experience this broader application of risk management in FDA investigations. ISO 13485 has a wider use of risk management, as opposed to risk analysis, in the current regulations. Also the application of risk-based thinking in 13485 requires the use of the risk management system.
This is an important concept, Naveen. As FDA shifts the QSR to the new QMSR and incorporation of ISO 13485:2016, manufacturers will experience this broader application of risk management in FDA investigations. ISO 13485 has a wider use of risk management, as opposed to risk analysis, in the current regulations. Also the application of risk-based thinking in 13485 requires the use of the risk management system.