Digital Compliance Platform for Medical Devices & IVDs

Digital compliance platforms for medical devices and IVDs. Vigi X™ for PMS & vigilance and Xceltrials™ for clinical evidence management.

Digital Compliance Platform for Medical Devices & IVDs

Bioexcel’s Digital Compliance Platform supports clinical evidence generation, post‑market surveillance,and regulatory traceability for medical devices and IVDs. Our platforms are designed to support regulatory workflows, enhance data integrity, and improve audit readiness under EU MDR, IVDR, and global regulations.

The platform suite includes Vigi X™ for materiovigilance and post‑market compliance, and Xceltrials™ for clinical evidence and study operations.