Clinical Investigations or studies are easily the most expensive and time–consuming endeavors undertaken by a medical device manufacturer on the path to CE Marking. Errors in communication, planning, conduct, evaluation, or reporting of clinical studies are currently the main causes for serious delay of market access in Europe. In this whitepaper, you will learn:
Note: This paper focuses on the actual situation in Europe only.
About the Author:
Jaap Laufer, MD, PharmD is Vice President of Regulatory and Clinical Affairs at Emergo.
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