Product certification body BSI has launched CE-Dedicated FastTrack, a new program to help medical device manufacturers reach European markets quickly and safely.

CE-Dedicated FastTrack offers product reviews within 45 working days, with BSI product experts dedicating a period of time to working exclusively with a particular client.

"BSI has tested the new CE-Dedicated program with some of our existing clients to glowing reviews," said Ibim Tariah, Technical Director, BSI Healthcare. "Clients found it to be cost-effective and appreciated the flexibility in the scheduling process. In addition, clients like the fact that BSI experts remain focused and dedicated over a specified number of days to ensure a high-quality, rapid review process."

Although BSI cannot guarantee product approval, the CE-Dedicated review enables manufacturers to assess their status earlier in the process and gives them a progress report for briefing upper management.

CE-Dedicated is not designed for products containing medicines or animal/blood derivatives.

"We listened to our customers and have expanded the toolbox to offer different solutions to fit specific customer requirements," said Paul Brooks, Vice President, BSI Healthcare. "CE-Dedicated demonstrates our continued commitment to view our services from the manufacturer's perspective in order to make them more predictable, interactive and effective. We firmly believe that CE-Dedicated will serve as a catalyst for change across the industry."

BSI provides testing and certification of services and products for Kitemark and CE Mark to UK, European and international standards.