ISO 14971:2019 requires that the manufacturer establishes, implements, documents and maintains an ongoing risk management process throughout the life cycle of the medical device. The required elements in this process and the responsibilities of top management are given in ISO 14971:2019 and explained in further detail in this document.
Please join us for a 1 hr session describing the requirements of ISO 1491:2019. This is an overview of the requirements. There will be time for a Q&A.