Don’t scramble days before. Learn how to be ready every day.
Three days before audit, you discover outdated SOPs and missing links? That’s not readiness — that’s roulette.
Stop audit panic withqmsWrapper’s connected QMS. Our AI-Powered QMS for MedTech builds audit readiness into your daily workflow with real-time visibility into missing documents and approvals for ISO 13485 compliance.
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qmsWrapper – Fully-Inclusive, AI-Powered QMS for MedTech
qmsWrapper is an AI-powered, all-in-one eQMS built for medical device and SaMD teams. It supports ISO 13485, ISO 14971, ISO 9001, FDA 21 CFR Part 820 & 11, EU MDR, IVDR, UK MDR/UKCA, MDSAP, and CE marking — in one unified platform.
All plans include every module and feature, with no restrictions. From CAPA, deviations, complaints, change and risk management, to document control, training, audits, supplier management, traceability matrix, electronic signatures, project management, and team collaboration — everything is available from day one.
AI enhances quality workflows by guiding event handling, supporting form completion, improving consistency, and helping teams stay audit-ready in real time. With built-in validation, flexible customization, and rapid onboarding, qmsWrapper enables fast, scalable compliance without enterprise complexity or hidden costs.
All features. All modules. One price. Built for regulated MedTech.
👉 Check our website: https://www.qmswrapper.com/
👉 Book a Meeting: https://meet.brevo.com/qmswrapper-dem...
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