BMI in launch of new product to speed up CE-mark process

September 2008
Medical Device Daily;9/16/2008, Vol. 12 Issue 198, p1
The article reports that a new speed-to-market program has been launched by BSI Management Systems of Reston, Virginia for Class III medical devices. The CE-45 FastTrack program expedites the review process in which most reviews are completed in 45 working days for medical devices headed to European markets. According to Paul Brooks of the BSI Product Services Healthcare, the goal of the program is to complete the review process with either a positive or negative recommendation.


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