Certification CE mark

CE Mark

Meeting EU safety, health, and environmental requirements

The CE mark appears on products in the EU to affirm that they comply with applicable EU regulations. BrightInsight works closely with our partners to complete the technical documentation (technical file), perform a conformity assessment, and issue the EU declaration of conformity to meet this important requirement.

In Q2 2023, BrightInsight earned CE marking in collaboration with a biopharma partner, affirming that our solution meets all relevant EU regulations. The patient companion app was reviewed by a Notified Body and the approval was received within four months of submission. Our team participates in audits and reviews with the Notified Body as part of the approval process.

By building the app using BrightInsight’s Quality Management System, our customers can feel confident that compliance to all EU regulatory, security and privacy requirements are ensured.

Back to Certifications