Case Study: Medical Microinstruments achieves MDR compliance and 500% enrollment growth with Castor EDC

Medical Microinstruments boosts enrollment 500% with Castor EDC

Medical Microinstruments (MMI), a pioneer in robotic microsurgery, needed a robust and user-friendly electronic data capture (EDC) platform to conduct a post-market clinical follow-up (PMCF) study. The study was required to fulfill EU Medical Device Regulation (MDR) requirements for their novel Symani Surgical System, and they faced challenges with patient enrollment and global data collection.

By implementing Castor EDC, MMI enhanced patient enrollment by over 500% and significantly increased data returns. The successful study maintained MMI's compliance with EU MDR and provided the data necessary to support their successful FDA De Novo application, which was granted in April 2024.

Medical Microinstruments (MMI)