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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 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 …
“Definitely we can organize better, trace efficiently and manage all our documentation and more. I am very satisfied with it and definitely I would recommend it to my colleagues and …
“qmsWrapper is a game-changer for us. It provides everything we need to ensure success in all aspects of our regulatory affairs at a price that is more than accessible for …
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