Are you a medical device manufacturer with your eye on the European market? If so, you've probably heard the term "CE Mark". The CE Mark is the key to selling your device in Europe, as all medical devices are required to bear this symbol. However, you can't simply stamp "CE" on your device.
The CE mark certifies that your device meets the requirements of the appropriate EU Directive. Showing your device conforms to these requirements is a complex process with lots of players. In this white paper, we'll answer your biggest questions about European CE Marking, including:
Learn all this and more in this 8-page white paper.
Elizabeth Pugh: Elizabeth Pugh is a Regulatory Affairs Consultant at Emergo. She has over 15 years of experience with regulat ory affairs in the medical devices industry, and previously held positions at Stryker, FoxHollow Technologies, and DJO Surgical. Her areas of expertise include CE Marking compliance, post-market surveillance, and global vigilance reporting.
我们的专家将详细解读2023年韩国食品药品安全部(MFDS)指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范(KGMP)等相关要求,并将依据多年韩国本地注册经验提供注册案例分享。此外,您还将了解到制造商在面对MFDS监管时需要关注的核心要点,相关研讨会内容包括:
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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