qmsWrapper

What qmsWrapper is

qmsWrapper is a cloud eQMS for medical-device, SaMD, IVD and growing manufacturer teams, available on Linux, Windows and the web. Its Foundation, Lifecycle and Vigilance levels let organizations add capabilities while retaining records and processes in one system. Foundation includes controlled forms and records, documents and approvals, training, tasks and storage; Lifecycle adds workflows such as CAPA, change control, deviations, nonconformities, feedback, supplier management and risk management. Vigilance covers post-market surveillance, Technical File visibility, and audit and regulatory evidence. AI assists with form completion, document search, change-impact analysis and traceability, while authorized users review and approve regulated decisions. The platform connects Jira projects and issues to its Traceability Matrix and risks. It lists 21 CFR Part 11 compliant electronic signatures and tamper-evident audit trails, and supports work aligned with frameworks including ISO 13485, ISO 14971, FDA QMSR and EU MDR. Foundation costs €3,499 per year; Lifecycle and Vigilance pricing depends on company size and scope. A 14-day trial is available.