Are you ready to sell your medical devices in the United States? Before you enter the US market, you need clearance from the US Food and Drug Administration, which means you probably need to submit a 510(k).
510(k) submissions, also known as Pre-Market Notifications, are required by the FDA for a range of medical device types and classifications. 510(k)s have unique content and format requirements – they are not identical to a European Technical File. And, the FDA's recent changes to 510(k) requirements make the submission process more rigid than ever. In this white paper, we will address your biggest questions about submitting a 510(k) in today’s market. What you will learn in this 10-page white paper:
We answer all of these questions and many more in this whitepaper.
Robert Seiple, RAC (US): Robert Seiple is Senior Regulatory Consultant at Emergo. He has over 35 years of experience with quality assurance and regulatory affairs in regulated industries, including medical devices, pharmaceuticals, and clinical research. His areas of expertise include 510(k) submissions, CE Marking, quality system implementation, training, and auditing.
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
阅读更多您可能已经听说,欧盟完善的医疗器械法规即将迎来变化。并且您可能有很多疑问。这些变化意味着什么,它们将如何影响您的公司? 欧盟新的医疗器械法规(MDR)将对医疗器械制造商进入欧盟市场的方式以及如何在产品的整个生命周期内维持合规产生重大影响。在这份长达28页的白皮书中,Emergo的
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