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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.
“It builds us a quality manual based on our specific requirement, shows us what processes to implement in order to adhere to said manual, walks us through those processes using …
"It builds us a quality manual based on our specific requirement, shows us what processes to implement in order to adhere to said manual, walks us through those processes using …
“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 …
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