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.
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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