BSI launches program for Class III medical device reviews.

BSI has developed a new program designed to expedite the medical device review process for products that require European CE Marking Design Dossier Reviews.

The program, called CE-Onsite FastTrack Review, expedites the review process through live, onsite interaction that facilitates more efficient communication. The program is designed to complete the review process in 45 working days, according to a news release from the company.

"The interactive aspect of the CE-Onsite FastTrack Review compresses the review time, improves the predictability of the re view's outcome, and promotes a faster time-to-market," said Ibim Tariah, technical director of BSI, Healthcare. "BSI provides thorough and fair reviews that focus on what really matters, but we never guarantee a CE Marking. The integrity of each review is critical to ensuring a medical device is deemed sale for its intended use."

The CE-Onsite Review is similar to the CE-45 FastTrack Program but has one major difference: BSI product experts visit the manufacturer in person to perform the review.

BSI officials said performing the review in person expedites the process by eliminating communication through mail, email, fax or phone. The face-to-face opportunity also gives product experts accessibility to all relevant parties in the review process.

The new CE-Onsite program gives product experts instant access to documents and allows them to see products for themselves. Despite the advantages of the program, BSI officials warned that the CE-Onsite system may not be suitable for medicinal, blood and animal tissue products. And, while the program is designed to complete the review process within 45 days, the length of the review could vary de pending upon the preparedness of the manufacturer.