The regulatory landscape is evolving: medical device regulators are expecting more mature risk management systems and processes. Further, recent standards revisions and emerging regulations - such as the European Medical Devices Regulation (MDR 2017/745) - show an increased emphasis on patient safety.
However, a mature risk management system does more than satisfy regulators and protect patients. It can boost products sales, increase customer loyalty, reduce the chance of product liability claims, and decrease your time to market. In this white paper, we discuss how the regulatory environment is changing and what you need to know to get the most out of your risk management system. You will learn:
Download our 9-page white paper to learn more about the future of risk management for medical device companies.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多要在欧盟合法销售体外诊断器械(IVD),您需要拥有证明其符合IVD法规的CE标识。CE标志表明合法制造商已经评估了器械,并且器械符合体外诊断器械指令98/79/EC(IVDD)的基本要求或体外诊断器械法规2017/746(IVDR)的一般安全和性能要求。合法制造商将验证它的器械是否符合所有相关
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