qmsWrapper B2B Case Studies & Customer Successes

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.