The Fastest and Most Experienced Routes to Global Markets
In the race to get new medical devices to market, speed is a critical component. BSI has a strong commitment to providing the most experienced and fastest routes to European markets. Our Programs have been developed especially for Class III medical devices needing CE Marking Design Dossier Reviews. They combine speed-to-market with the integrity, independence, predictability and thoroughness that you have come to expect from BSI.
BSI is a technology-driven organization and has the product expertise, knowledge and tools you need. We employ state-of-the-art technology that offers many e-solutions that enhance dossier submissions as well as the review process. We strive to advance our systems to encourage transparency, speed and reliability.
Our clients enjoy working with us because we know what medical device manufacturers face in getting compliant products on the market quickly. We are continually developing Speed-to-Market Programs to meet the demands of the medical device industry. The following are our CE Marking programs.
CE-90 Standard
BSI has set a new level of service in the industry. The CE-90 is our standard CE marking design dossier program in which most reviews are completed within 90 working days from submission. You will have confidence knowing that we conduct robust, comprehensive assessments that will stand up to scrutiny while giving you more predictability for better results.
CE-45 FastTrack
We make getting your product to global markets as important to us as it is to you. BSI knows every day can have an impact on the bottom line, so we created the CE-45 FastTrack Program. The CE-45 is an expedited design dossier service where most reviews are completed within 45 working days from submission. Our goal is to assist you in getting your products to market faster, realizing a faster return on your investment.
Onsite FastTrack
Onsite FastTrack Review Program is conducted at the customer’s premises, in which BSI Product Experts visit the facility for a dedicated period of time. This expedited service is designed for customers who are prepared and ready-to-go to market. It works toward a CE Marking target of 45 working days from submission. Onsite Reviews usually allow for a much faster timeline with dynamic communications and opportunities for immediate response to questions. Real time - for real results.
Note: Our Programs do not guarantee a CE Marking certificate will be issued in a certain amount of working days but is based on completing the review process with either a positive or negative recommendation. It excludes reviews outside BSI’s control (e.g., medicinal, animal and/or blood products).
