Europe is the world's second-largest medical device market with 500+ million people and 20+ languages. Fortunately there is only one approval process (CE Marking) for medical devices that grants you access to all 32 countries. In this detailed 21 minute, seven part slidecast, we will demystify the process of bringing your device to market in the EU, break it down into understandable steps and explain each one. Once you begin the series you may skip to the next section at any time using the playlist in the player window.
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
阅读更多近年来,全球医疗法规监管日新月异,各国、各地区监管机构纷纷出台、变更当地法规。与此同时,作为全球第一大医疗器械市场的美国,在其法规领域也做出诸多变化。这给不少以上市美国市场为目标的医疗器械企业及制造商带来了不小的挑战。 对此,Emergo by UL法规专家团队准备举办一场线上研
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