Risk Management Plan Template , which can be used as starting point for the practical implementation of the risk management process.Risk Management Procedure , to ensure that the risk management process is well defined within your Quality Management System.In fact, in the QualityMedDev DocShop, the following documentation can be downloaded: In order to support the implementation of an efficient risk management process, QualityMedDev provides different documentation which can definitely help your organization in the implementation, reorganisation or improvement of risk management. The regulation in the last 10 years shifted completely towards a situation where risk management process is at the core of quality management system and technical documentation for medical devices.
Nobody can deny the importance of risk management in the medical device field. QualityMedDev Risk Management Documentation
