Many medical device companies think they are ready to conduct clinical investigation studies when they are actually months--if not years--away from initiating a study in Europe. This can be a costly mistake.
It's important to understand the clinical study requirements in any market before moving forward, but especially in Europe. Investing in a study that does not comply with the MDD requirements could delay your certification process.
In this white paper, we'll discuss European clinical investigation requirements and how to know when you're ready for this important step.
You will learn:
We'll answer all these questions and much more in this 6-page white paper.
About the Author:
Danielle Avadis, M.D. is the Medical Director of Emergo's Israel Office.
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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