Ready to sell your medical devices in Europe? First, you must comply with Europe’s medical device regulations. But instead of a one-size-fits-all approach, there are many ways to demonstrate your compliance – also known as conformity assessment routes.
The conformity assessment route makes it easy for the Notified Body to verify your compliance to the MDD and Essential Requirements. There are many routes to choose from, and your chosen route has implications for your business that you might not expect. How do you know which route is best for you?
What you will learn in this 4-page white paper:
We answer all of these questions and many more in this whitepaper.
About the Author:
Evangeline Loh, Ph.D. RAC (US, EU)
Evangeline is Vice President of 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
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