Want to sell your medical device in Europe? If the answer is yes, you probably have a lot of questions about one of the key elements of the European regulatory process: the CE Technical File.
Preparing your CE Technical File takes precision and care, as the requirements for data, documentation, and formatting of this document are very specific. In this white paper, we demystify this important document and answer your biggest questions about how to prepare a Technical File, including:
We answer all of these questions and more in this 8-page white paper.
Evangeline Loh, Ph.D., RAC (US/EU): Evangeline is Vice President of Global Regulatory Affairs at Emergo. Evangeline's areas of expertise include European CE Marking, clinical evaluation reports, vigilance, and device classification in markets worldwide. She previously worked for Cook Medical and holds a Ph.D. in pharmacology from The University of Texas Health Sciences Center at San Antonio.
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
阅读更多请参考下列加拿大卫生部对外公布的PDF文件。 关于医疗器械法规的链接 加拿大卫生部——
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