Dedicated BSI Product Experts—Dedicated to You.
BSI CE-Dedicated FastTrack Program is designed for Medical Device Manufacturers needing to get their products to European markets quickly and safely. This premium CE Marking Program is for high risk medical devices requiring design dossier reviews. We provide you the same high quality reviews just at an accelerated rate, usually within 45 working days or less.
CE-Dedicated Benefits
- Speed-to-Market Benefits with Same High Quality Reviews
- Dedicated Time Period with BSI Product Experts
- CE Marking for Class III Medical Devices
- Reviews Completed in 45 Working Days
- Customized and Flexible Review Scheduling
- No Traveling to Customer Site Required
- Patients Gain Faster Access to New Medical Technology
How it Works
Our experienced and knowledgeable BSI Product Experts dedicate a specific period of time committed solely to working with you and your team to complete the review. Employing an array of communication technologies, paperless submissions and our expertise we bring you a technically advanced environment to accelerate medical device launches. The steps include:
- Evaluate if FastTrack is a good fit for the product and the company
- Conduct Customer needs analysis
- Estimate number of Dedicated review days and schedule
- Perform pre-review preparation meeting to organize resources
- Conduct CE-Dedicated Review
- Discuss next steps and process review as necessary
BSI is a Notified Body and Registrar governed by the highest of standards to ensure effectiveness, safety and independence. Let us help you get on the FastTrack to CE-marking your product.
Download more on CE-Dedicated FastTrack Reviews (PDF 168 KB)
Note: Programs do not guarantee a CE Marking certificate in a certain amount of working days but commits to completing the review process with either a positive or negative recommendation. Programs exclude reviews outside BSI’s control (e.g., products containing medicines, animal or blood derivatives).
