Are you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision medicine. Second, they come with some unique regulatory challenges because they are considered pharmaceuticals and medical devices.
The United States and Europe take a unique approach to regulating these innovative devices. In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.
What you will learn in this 5-page white paper:
We answer all of these questions and many more in this white paper.
Oliver Eikenberg, PhD is Senior QA/RA Consultant at Emergo's office in Hamburg, Germany. His areas of expertise include QMS implementations and regulatory submissions in the US and Europe, particularly for IVDs in the areas of neurology, infectious disease, autoimmune disorders, cancer, genetic markers, and CDx. He holds a PhD in chemistry from the Technical University of Munich.
新欧盟体外诊断器械法规(IVDR,In Vitro Diagnostic Device Regulation (EU) 2017/746)IVDR的发布为体外诊断器械医疗器械制造商满足欧洲市场合规带来新规实施、新旧过渡的诸多前所未有的挑战。对此,全球医疗器械及IVD器械合规专家Emergo b
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