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qmsWrapper

AI-enabled eQMS for Medical Device, SaMD and IVD Teams

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qmsWrapper is an AI-enabled eQMS for medical device, SaMD and IVD teams. It provides a connected quality system with three levels: Foundation (controlled forms, documents, training), Lifecycle (quality events, CAPA, change control, risk management), and Vigilance (PMS, vigilance, technical-file traceability, audit readiness). The platform uses Event-to-Evidence AI to help users identify needed records, affected procedures, and evidence for auditors. It supports ISO 13485, ISO 14971, FDA QMSR, EU MDR, and 21 CFR Part 11 compliance.

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