qmsWrapper

What is qmsWrapper?

qmsWrapper is a quality management system (QMS) for medical device, software as a medical device (SaMD), and in vitro diagnostic (IVD) organizations. The platform manages quality processes, product-lifecycle records, and post-market activities.

Key Capabilities

Foundation: qmsWrapper manages controlled documents, forms, training records, and core quality processes.
Lifecycle: The platform connects quality events, corrective and preventive actions (CAPA), change control, risk management, technical files, and traceability records across the product lifecycle.
Vigilance: The Vigilance level adds post-market surveillance, regulatory oversight, audit-readiness functions, and AI governance controls.
Progressive deployment: Each platform level extends the preceding level, allowing organizations to add capabilities while retaining existing records and configurations.
Regulatory support: qmsWrapper supports quality-management workflows associated with ISO 13485, ISO 14971, FDA Quality Management System Regulation (QMSR), FDA 21 CFR Part 11, and the EU Medical Device Regulation (MDR). The platform includes AI assistance, human-review workflows, and traceability controls.

Audience & Use Cases

Audience: Quality, regulatory, clinical, and product teams at medical device, SaMD, and IVD organizations.
Use case: Managing controlled quality documentation, product changes, risk records, CAPA activities, technical files, and post-market surveillance.