Real-Time Reviews for Real-Time Results
Utilizing CE-Onsite can result in a more rapid product launch, quicker return on investment and patients getting products faster.
BSI CE-Onsite FastTrack Review is a part of our innovative Speed-to-Market Programs* developed for medical devices needing Design Dossier Reviews for European Markets. CE-Onsite Review* is conducted at the customer’s premises in which BSI Product Experts visit the facility for a dedicated period of time. This expedited, interactive service works toward a CE Marking target of 45 working days or less from submission.
CE-Onsite Benefits
- Experienced Product Experts Visit Client Site
- CE Marking for Class III Medical Devices
- Reviews in 45 Working Days
- Patients Gaining Access to New Technology Sooner
- Quicker Return on Investment.
- Dynamic Exchange of Information
- Global Launch Capability
Performing reviews onsite allows for a much faster timeline while still maintaining the same high quality reviews that stand up to scrutiny. This face-to-face opportunity provides Product Experts accessibility to all relevant parties, from engineers to regulators and supports dynamic communication, immediate access to documentation and in-person viewing of the new product.
However, this premium program is not for every product as some products containing medicinal, animal and/or blood derivatives require the use of outside agencies and may not be eligible for CE-Onsite Review. In addition, the length of the review greatly depends on the degree to which the manufacturer is prepared. In order to make the review as effective as possible, clients should have a strong motivation to get their product to market, excellent documentation, be well-organized and responsive to questions.
Manufacturers utilizing the CE-Onsite FastTrack Reviews have experienced numerous advantages including shorter launch times, patients gaining access to new technology sooner and quicker return on investment.
Download more on CE-Onsite FastTrack Reviews (PDF 391 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).
