The European Union is aiming to mirror the FDA in terms of the medical device approval process. How can Sponsors mitigate against the additional costs?
The EU has put legislation into place for an approval system of high tech medical devices that mirrors the approval process of the FDA. What are the requirements for the EU and how can Sponsors keep costs under control?
Medical Device companies have their share of complexities including regulatory challenges, a widening range of product types and applications that can require unique statistical analyses and study designs.