AI-powered quality management system for medical device manufacturers that automates change impact analysis, maintains technical file traceability, and ensures regulatory compliance across FDA QMSR and EU MDR requirements. Integrates controlled processes, CAPA workflows, vigilance tracking, and audi...
Manufactured by
QMS Wrapper Ltd.
Markham (ON), Canada
qmsWrapper is a next-generation eQMS built for forward-thinking medical device teams who want more than compliance — they want a connected, intelligent, and future-ready system. It unites the Quality Event System (QES) and Design History System (DHS) into one closed-loop environment where every event, change, and CAPA seamlessly links to design, risk, and verification records. Built on form-driven workflows, dynamic logs, and AI-ready architecture, qmsWrapper transforms quality management into a transparent, automated, and continuously learning ecosystem — ensuring ISO 13485, FDA 21 CFR Part 820, and EU MDR compliance as a natural outcome of efficient work. From design input to post-market feedback, qmsWrapper connects every process through intelligent workflows, risk-driven event and hazard logs, and adaptive traceability — giving QMS managers real-time control, predictive insights, and effortless audit readiness in the era of AI-enabled compliance.
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