Medical device manufacturers face challenges due to changing regulations, varying employee engagement in quality culture and managing high volumes of information. Our Closed Loop Quality and Compliance tools allow digital tracking, improved efficiency and enhanced collaboration with health authorities. Our solution integrates a digital backbone for data flow automation, electronic signatures and multi-disciplinary team coordination. Our Regulatory Information Management System (RIMS) based on low-code apps streamlines product registration and adverse event reporting, providing comprehensive, up-to-date information for pre-market submissions, post-market reporting and audits, ultimately reinforcing medical device quality through continuous monitoring.
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