QMS Wrapper

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.