新版ISO14971标准和MDR的风险管理要求.pdfVIP

11/12/2019 新版ISO14971介绍以及欧盟MDR 对风险管理的要求 New ISO 14971 and Risk Management required by MDR 计利方 Lane JI Medical Devices Director of BSI China Active Device Scheme Manager and Product Specialist Copyright © 2019 BSI. All rights reserved 1 11/12/2019 内容提要Content 1. ISO 14971标准历史和简介 ISO 14971 history introduction 2. 新版ISO 14971:2019的变化 Changes to New ISO 14971:2019 3. 欧盟MDR对风险管理的要求 Risk management required by MDR 2 11/12/2019 1 11/12/2019 Disclaimer 声明 • Information presented is based on our current understanding of the Risk manager and MDR • Subject to change 3 3 Copyright © 2019 BSI. All rights reserved 医疗器械风险管理标准YY/T0316:2016 EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices