Clinical fast track to market.

pubblicato venerdì 22 giugno 2012

Clinical results are the central element for any medical therapy. The right approach for presenting the data will speed up market approval and support rapid adoption of new technologies.

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Clinical fast track to market.

Manufacturers of innovative technologies are facing new challenges in approaching the EU marketplace. More clinical data are required by the new European Directives enforced in 2010.

At stake for manufacturers is continued participation in the growing $86 billion European market, which accounts for a significant percentage of profits for most U.S. medical device companies.

Manufacturers must now take immediate steps to comply by following the new EU guidelines. These are quite complex, however, they are harmonized with global requirements. Therefore, literature reviews and data evaluations can now be used for world wide purposes.

For US manufacturers, adoption of these new guidelines is not an exercise for the EU only but standard practice world wide.
Furthermore, optimal presentation of the data will create confidence in the product, foster enthusiasm and provide an ideal framework for product launch.

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