CiteMed

CiteMed provides an AI-assisted evidence management platform for medical device teams working with MDR, IVDR, and FDA requirements. Its Evidence Cloud brings clinical evidence workflows together, helping organizations manage literature reviews, safety data, and regulatory documentation. The platform’s independent modules include Literature for streamlining searches, screening, and structured review outputs; CiteSource for organizing literature, references, and source documents in a review-ready library; and Vigilance for managing safety data, detecting potential signals, and generating reports. Pathway supports writers with context for creating compliant content, while ReadyView helps transform evidence into submission-ready documents using templates and export tools.

CiteMed highlights AI-assisted guidance, workflow compatibility, and built-in validation documentation designed to support audit readiness. Its platform can generate CERs, PMSs, PMCFs, PSURs, vigilance reports, and other regulatory documents. Modules may be purchased separately, and the company offers activation and advisory services, with onboarding recommended for new teams. CiteMed states that data is stored in SOC-compliant data centers and aligned with GDPR and major data privacy requirements.