# qmsWrapper

> qmsWrapper is a Medical Device Compliance QMS, an AI-Powered eQMS for ISO 13485, FDA QMSR, 21 CFR Part 11, EU MDR, EU IVDR, ISO 14971, IEC 62304, the EU AI Act and ISO 27001. Powered by Event-to-Evidence AI, it turns every quality event into audit-ready evidence with human-in-the-loop approval. Built for Medical Device, SaMD, IVD and MedTech SMEs.

## Start here
- [What is qmsWrapper](https://qmswrapper.com/what-is-qmswrapper/): Definition, who it is for, and how the platform works.
- [qmsWrapper Technical Overview](https://qmswrapper.com/qmswrapper-technical-overview/): Architecture, 22 modules across 4 layers, and the cross-cutting AI capabilities.
- [Medical device QMS software](https://qmswrapper.com/medical-device-qms-software/): Product overview for medical device companies.

## Compliance and standards
- [ISO 13485, FDA and EU MDR compliance](https://qmswrapper.com/iso-13485-fda-compliance/): How qmsWrapper maps to the core regulations.
- [FDA QMSR software](https://qmswrapper.com/fda-iso-13485-qms-software/): FDA QMSR (21 CFR 820 aligned to ISO 13485:2016) support.
- [ISO 14971 risk management](https://qmswrapper.com/iso-14971-risk-management/): The risk management file from hazards to verification.

## Core modules
- [CAPA and non-conformance](https://qmswrapper.com/capa-and-non-conformance-qms/): Structured corrective and preventive action.
- [Document control and 21 CFR Part 11 e-signatures](https://qmswrapper.com/document-control-and-electronic-signatures/): Controlled documents, approvals and tamper-evident signatures.
- [Change and deviation management](https://qmswrapper.com/iso-13485-change-and-deviation-management/): Change control with automated change-impact analysis.
- [Audit management](https://qmswrapper.com/audit-module/): Internal and notified-body audits.
- [Supplier management](https://qmswrapper.com/supplier-mgmt-and-manufacturing/): Supplier qualification and monitoring.
- [Complaint handling and vigilance](https://qmswrapper.com/customer-complaints-management/): Complaints and reportable vigilance cases.
- [Design control and traceability matrix](https://qmswrapper.com/design-control-traceability-matrix/): Requirements, risks, design and tests linked end to end.
- [Training and competency management](https://qmswrapper.com/medical-device-training-competency-management/): Documented competence evidence.
- [Event-driven QMS](https://qmswrapper.com/event-driven-qms/): The Quality Event System intake.
- [Project quality management](https://qmswrapper.com/project-quality-management-medical-devices/): Devices, teams and milestones in one place.

## Architecture (Technical Overview chapters)
- [Foundation layer](https://qmswrapper.com/foundation-layer/): Logs, document control, approvals, audit trail.
- [Design-cycle layer](https://qmswrapper.com/design-cycle-layer/): Technical File, risk, traceability, UDI, training.
- [Post-market layer](https://qmswrapper.com/post-market-layer/): Vigilance, CAPA, EUDAMED.
- [Governance layer](https://qmswrapper.com/governance-layer/): Management review, audits, supplier control, AI governance, cybersecurity.
- [Cross-cutting AI capabilities](https://qmswrapper.com/cross-cutting-capabilities/): Change-Management AI, Smart Impact Mapper, Regulatory Health Score, AI Findings Inbox with human-in-the-loop.
- [Event-to-Evidence AI](https://qmswrapper.com/ai-qms-for-medical-devices/): The AI that turns events into evidence.

## Comparisons and alternatives
- [qmsWrapper vs Greenlight Guru](https://qmswrapper.com/greenlightguru-alternative/): Side-by-side feature and pricing comparison for MedTech teams evaluating both platforms.
- [qmsWrapper vs Qualio](https://qmswrapper.com/qmswrapper-vs-qualio/): Side-by-side comparison for teams considering Qualio.

## Demo and pricing
- [Book a demo](https://meet.brevo.com/qmswrapper-demo/intro): Schedule a live walkthrough with the qmsWrapper team.

## Agent knowledge bundle (OKF)
- [Knowledge bundle index](https://qmswrapper.com/okf/index.md): Structured OKF bundle — agent-readable map of all modules, compliance standards, and AI capabilities.
- [Product overview](https://qmswrapper.com/okf/product/overview.md): What qmsWrapper is, who it is for, key differentiators.
- [Architecture](https://qmswrapper.com/okf/product/architecture.md): Three-layer model (Flow / Control / Vigilance) and AI capabilities.
- [Modules](https://qmswrapper.com/okf/modules/index.md): All 10 core QMS modules with regulatory mapping.
- [Compliance standards](https://qmswrapper.com/okf/compliance/index.md): ISO 13485, FDA QMSR, EU MDR, ISO 14971, IEC 62304, EU AI Act.
- [AI capabilities](https://qmswrapper.com/okf/ai-capabilities/index.md): Change Impact Analysis, Smart Impact Mapper, Regulatory Health Score.

## Key facts
- Pricing starts at €3,499 per year, based on the capability level you need (Foundation, Control, Vigilance) — users are uncapped at every level.
- Every plan includes all modules, AI features, validation documentation, and lifetime support. No locked modules, no hidden costs.
- FDA QMSR (21 CFR 820 aligned to ISO 13485:2016) became effective 2 February 2026.
- AI proposes; humans approve every regulated action with a PIN-validated 21 CFR Part 11 signature (EU AI Act Article 14 human-in-the-loop).
- Typical implementation is 2 to 3 days; most teams are productive within 2 to 3 hours.