Run Your EU MDR PMCF Program On One Platform

A European Class III implantable-device manufacturer ran its PMCF study on one platform, from retrospective baseline through database lock, with a two-person clinical team and more than eight surgical sites. The program paired multi-year prospective follow-up with a retrospective record that still had to hold up to the notified body. Along the way, AI-driven chart review with human review built the baseline, eConsent kept patients enrolled remotely, and automated ePRO surveys at 1, 3, and 5 years replaced manual chasing. The write-up also lists the certifications and standards behind the data handling, including ISO 27001, 21 CFR Part 11, GDPR, and ISO 14155.

Talk to Castor about how your EU MDR PMCF program could be run the same way.