Moreover, QualityMedDev has recently published an e-book focused on risk management process for medical device sectors. Risk Analysis Template, which provides you a great example of template that can be used for your risk analysis.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 template includes instructions to the author, boilerplate text, and fields. 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. This document is a template of a Risk Management Plan document for a project. Nobody can deny the importance of risk management in the medical device field. Please complete the form to access this resource. Just getting started with risk management This White Paper provides a high-level overview of ISO 14971:2019 and an overview of key concepts you should know about before formulating a plan. ![]() ![]() QualityMedDev Risk Management Documentation Medical Device Risk Management 101 Learning the basics of how to analyze, evaluate, control, and monitor risk.
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