qmsWrapper is unclaimed —

qmsWrapper

Medical Device QMS Software for Startups & SMEs·qmswrapper.com

qmsWrapper is a cloud-based electronic quality management system (eQMS) designed for medical device and MedTech companies. It is pre-configured for ISO 13485, FDA QMSR, EU MDR, and ISO 14971 compliance, connecting documents, quality events, CAPA, risk management, training, suppliers, and traceability into one system. It uses 'Event-to-Evidence AI' to turn quality events into audit-ready evidence, with human approval required for regulated decisions.

What it's for

Managing CAPA and non-conformanceChange and deviation managementISO 14971 risk management and hazard logsDesign control and traceability matrix / DHF maintenanceDocument control with 21 CFR Part 11 e-signaturesCustomer complaints and vigilance handlingInternal, external, and supplier audit managementSupplier qualification and monitoringTraining and competency trackingProject and quality management in one workspaceEvent-driven quality event intake and triage

Features 20

AI Help Assistant for contextual guidance
AI Knowledge Search across documents, risks, and events
AI Risk Assistant for risk analysis updates
Audit management for internal, external, and supplier audits
Built-in team messaging and meeting records
CAPA and non-conformance management with closed-loop workflows
Change and deviation management with impact analysis
Custom Form Editor for building web-based forms without coding
Customer complaints and vigilance handling
Design control and traceability matrix linking requirements, risks, design, and tests
Document management with 21 CFR Part 11 electronic signatures
Event-driven Quality Event System (QES)
Integration with Jira for engineering issue tracking
ISO 14971 risk management with hazard logs
Process Workflow Editor for mapping SOPs into digital workflows
Smart Form Assistant that pre-fills forms and flags missing data
Supplier management and manufacturing quality tracking
Traceability Matrix automation
Training and competency management
Wrapper Mapper for change impact analysis across the Technical File

At a glance

TypeWeb app

DeploymentCloud

PlatformsWeb

ForMedTech startups, medical device manufacturers, diagnostics and biotech companies, SaMD teams, ISO 13485 organizations, quality and regulatory teams, medical device startups and SMEs

CompanyqmsWrapper

Integrations

Jira

Complianceself-reported

ISO 13485FDA QMSR21 CFR Part 82021 CFR Part 11EU MDRIVDRUKCAISO 14971IEC 62304IEC 82304ISO 8000-2ISO 14155UK DCB0129DCB0160EUDAMEDMHRAGDPRHIPAAISO 27001SOC 2MDSAPISO 9001EU AI Act510(k)

Pricing

Pricing starts at €3,499 per year, based on the capability level chosen (Foundation, Control/Lifecycle, Vigilance); users are uncapped at every level. Every plan includes all modules, AI features, validation documentation, and lifetime support, with no separate modules or hidden costs.

qmsWrapper (starting price)Quote

Stated as the starting price for the platform; exact price per capability level not disclosed

Pricing varies by capability level (Foundation, Control/Lifecycle, Vigilance); users uncapped at every level