Europe is the world's second-largest medical device market with 500 million people, 20+ languages, 32 countries and (fortunately) only one approval process. This short video gives you a high level overview of the CE Marking process in Europe as it exists currently under the Medical Devices Directive (93/42/EEC). We discuss how devices are regulated, classification of devices, the role of your EC REP, QMS requirements and more. Read more about our European CE compliance services or download this free chart on the medical device approval process in Europe.
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
阅读更多新欧盟体外诊断器械法规(IVDR,In Vitro Diagnostic Device Regulation (EU) 2017/746)IVDR的发布为体外诊断器械医疗器械制造商满足欧洲市场合规带来新规实施、新旧过渡的诸多前所未有的挑战。对此,全球医疗器械及IVD器械合规专家Emergo b
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