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 the European clinical investigation requirements as well as how to know when you're ready to proceed with this important step.
You will learn:
- How did European clinical studies regulations evolve in recent years?
- How did MDD updates and ISO 14971 affect companies seeking clinical studies in Europe?
- What regulations should we know before conducting clinical studies?
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.