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qmsWrapper is a Quality Management System (eQMS) designed specifically for medical device startups and SMEs. Instead of forcing organizations into a complex enterprise platform from day one, qmsWrapper grows with your business through three connected editions: Foundation, Lifecycle and Vigilance.
Start with controlled documents, forms, workflows and training, then expand into connected quality processes, risk management, technical documentation, traceability and post-market activities as your organization grows.
Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11 and EU MDR, qmsWrapper combines human-controlled AI assistance with complete traceability and audit-ready evidence, helping medical device companies build, manage and scale their Quality Management System with confidence.
“qmsWrapper holds your hand through the design control and risk management process, which is especially valuable for a company without much experience going through these processes. You still have to …
“qmsWrapper is an essential tool in ensuring compliance with quality and risk management standards, helping us to intuitively and easily build and implement the workflows for documentation and process management …
“Being a small start-up company, having ISO 134185 to maintain and CE and FDA pending, we are quite happy how we use this software. The custom forms help us to …
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