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AI-enabled eQMS for regulated medical-device teams

Medical Device QMS Software for Startups & SMEs

qmsWrapper helps medical-device, SaMD, IVD and MedTech teams convert their paper QMS through 3 levels of audit readiness. Start by building your QMS foundation: turn paper forms, Word templates and spreadsheets into controlled eForms, training and document management. Grow into ISO 13485 workflows and risk management. Mature into Technical File traceability, PMS, audit evidence, FDA QMSR, UKCA, Health Canada and EU MDR visibility.

From paper QMS to connected Vigilance.

    Low Risk Implementation: Level 1 - Flow. Level 2 - Control. Level 3 - Vigilance. Start where the need is greatest. Keep what you build. Migrate when ready.

    Convert One Paper Form Map One Quality Event

    How does qmsWrapper turn a quality event into audit-ready evidence?

    qmsWrapper is a medical-device compliance platform for startups and SMEs that are outgrowing paper, spreadsheets, shared drives and disconnected quality records. It gives companies a practical way to move from basic controlled processes into a connected QMS, and then into a full vigilance and regulatory evidence system. The platform is structured in three tiers: Wrapper Process for controlled forms, taskforms, logs, processes and guided ISO 13485 foundations; Wrapper QMS for quality events, CAPA, change control, deviations, non-conformities, feedback, suppliers, training and risk-linked quality workflows; and Wrapper Vigilance for PMS, vigilance, technical-file impact, regulatory evidence, EUDAMED preparation, EU AI Act support, audit readiness and controlled AI-assisted evidence preparation. qmsWrapper is built around Event-to-Evidence AI: when something happens in the company, qmsWrapper helps identify what records are needed, what procedures may be affected, what risks may change, what technical-file sections may need review, and what evidence an auditor, notified body, regulator or customer may later expect to see. AI assists the user, but the user remains in control. qmsWrapper makes compliance more visible, connected, traceable and manageable without pretending that regulation has become simple.

    What is qmsWrapper?

    qmsWrapper is an AI-enabled eQMS for medical-device, SaMD, IVD and MedTech SMEs. It connects controlled forms, taskforms, processes, quality events, CAPA, change control, risk management, training, suppliers, feedback, non-conformities, vigilance, Technical File and Traceability Matrix evidence into one structured QMS environment, implemented in 3 Layers of audit-readiness preparations.

    Built for ISO 13485, FDA QMSR / 21 CFR Part 820, 21 CFR Part 11, EU MDR, IVDR, UKCA, ISO 14971, IEC 62304, IEC 82304, ISO 8000-2, ISO 14155, UK DCB0129, DCB0160, Health Canada, EUDAMED, MHRA, and SaMD regulatory standards. qmsWrapper helps teams move from paper-based QMS records to connected regulatory evidence, with AI assistance and human approval at each level.

    Full overview →

    A connected system with three capability layers

    Flow. Control. Vigilance. Expand when ready.

    Start with the capability you need today. Add the next layer without rebuilding your QMS or losing the records, processes and evidence already created.

    qmsWrapper Flow

    Flow
    • Audit-traceable eForms and taskforms
    • From paper QMS to controlled processes.
    • Form Assist, Storage, Project MCP

    qmsWrapper Control

    Control
    • Regulated quality workflows
    • CAPA, Change, N-C, Deviation, Feedback, Training, Suppliers and Risk.
    • AI Assist, Workflow and Risk MCP

    qmsWrapper Vigilance

    Vigilance
    • Evidence-ready oversight
    • TF/TM, PMS, audit evidence, FDA QMSR and EU MDR visibility.
    • AI Assist, PMS, TF/TM, audit and regulatory MCP

    Controlled AI and MCP access for approved AI agents.

    Level appropriate AI agents can search, draft, summarise, propose links and prepare evidence. They do not approve CAPA closure, reportability, significant change decisions, risk acceptability, Technical File release or regulated submissions.

    Wetling BreatheSuite Miridia Liberty Vision KeborMed Grownetics Glyciome Spars Getica Digital MedLab AbilityMade 4D Path Otn implants Inova medical iAssay Vocare United Vein Titus medical Molbiol Smellcells Simple HealthKit Saccade Realize Medical Meditec Peek Vision Globe biomedical Fujifilm Fovia Cosiam Cheelcare Calon-cardio AlBayader

    Who it's for

    Built for medical device teams ready for an intelligent QMS where AI does the heavy lifting

    Automated change management, smarter CAPA workflows, and connected traceability, without manual overhead.

    Who benefits most from qmsWrapper…

    • MedTech startups targeting ISO 13485, FDA QMSR, or CE
    • Medical device teams with FDA 510(k), MDR, or UKCA
    • Diagnostics and biotech managing traceability and risk
    • SaMD teams navigating FDA and IVDR requirements
    • ISO 13485 organizations reducing compliance overhead
    • Quality and regulatory teams on CAPA and compliance
    medical device compliance professionals discussing quality and regulatory documentation

    The problem

    Your QMS Should Support Your Team,
    Not Slow Them Down

    Many QMS platforms still force teams into manual maintenance, disconnected workflows, duplicated records, and audit preparation that takes months.

    • manage endless documents manually
    • maintain traceability spreadsheets
    • duplicate information across multiple records
    • fill out repetitive forms and CAPAs
    • chase approvals across disconnected workflows
    • spend months preparing for audits

    And even worse: many “AI-powered QMS” platforms still operate like document repositories with automation layered on top.

    The result?

    Quality teams spend too much time maintaining the system instead of improving quality.

    Where Quality Teams Spend Their Time

    Traditional QMS

    Documentation maintenance
    40
    Audit preparation
    30
    Quality improvement
    30

    With qmsWrapper

    System maintenance
    10
    Documentation management
    20
    Quality improvement
    70

    AI that actually runs your QMS

    Not marketing AI. Operational AI.

    This AI QMS for medical devices uses operational AI to actively manage your quality system.

    qmsWrapper includes AI agents that actively maintain your quality system, rather than sitting on top of a static document repository.

    Traceability Matrix Automation

    Automatically creates and maintains traceability across requirements, risks, and verification.

    AI Risk Assistant

    Builds and updates risk analysis based on real system data and changes.

    AI Form Completion

    Pre-fills quality forms using existing data: faster, consistent, audit-ready.

    AI Event Intelligence

    Captures and manages deviations, CAPAs, and quality events with full context.

    AI Knowledge Search (CORE)

    Find answers across your entire QMS instantly: documents, risks, events, everything.

    Wrapper Mapper: Change Impact Analysis

    Identifies exactly what changes when something changes, across your Technical File.

    This is not automation.

    This is an intelligent quality system.

    AI that actually runs your QMS

    What Your Quality System Looks Like
    with qmsWrapper

    • Traceability is continuously maintained
    • Risk management integrates with design controls
    • Forms are pre-filled with existing data
    • Quality events remain structured and auditable
    • Documentation remains consistent across the system

    Your team can focus on improving product quality and safety, instead of maintaining infrastructure.

    Design Control Software for Medical Devices: Laptop screen displaying the qmsWrapper Traceability Matrix with linked use cases, requirements, risk levels, risk mitigation, and test records in a live, connected DHF view.
    AI QMS for medical devices: qmsWrapper flexible QMS system diagram showing connected modules with traceability and controlled workflows

    FLEXIBILITY

    Built Around Your Processes, Not Rigid Software Workflows

    Many enterprise QMS platforms force organizations to adapt their processes to the software.

    qmsWrapper is designed differently.

    Workflows, modules, and traceability structures are configurable and interconnected, allowing your quality system to evolve naturally as your organization grows.

    qmsWrapper adapts to your processes, not the other way around.

    Platform overview

    Everything your QMS needs, in one connected platform.

    Flexible, interconnected modules that adapt to your processes instead of forcing rigid software workflows.

    • Document Management  & Electronic Signatures
    • Design Controls
    • Traceability Matrix
    • Risk Management (ISO 14971)
    • CAPA & Nonconformities
    • Training Management
    • Supplier Management
    • Customer Complaints
    • Change &  Deviation Management
    • Audit Management

    Every module benefits from AI-assisted functionality and deep system integration.

    qmsWrapper QMS modules including CAPA, risk management, traceability matrix, and document control in a connected system

    Compliance confidence

    Built for Regulated Environments

    Built as an AI QMS for medical devices, every action is recorded, traceable, and audit-ready.

    Your documentation, processes, risks, and verification activities remain continuously connected and audit-ready.

    What auditors like

    Clarity, traceability, and consistency

    qmsWrapper organizes quality records so auditors can easily follow relationships between:

    • user needs
    • requirements
    • risks and mitigations
    • design inputs and outputs
    • verification and validation
    • CAPAs and quality events

    All records include version history, electronic signatures, and full audit trails, allowing audits to become structured system reviews, instead of piecing together evidence across multiple files.

    Modern, clean team workspace in the foreground with four professionals collaborating around a white desk, while a large, blurred corporate office environment fades into the background, symbolizing complexity versus clarity. ISO 13485 QMS software

    Through my 20+ years in the regulatory industry, I've worked with several QMS software solutions, enough to make meaningful comparisons. qmsWrapper is comprehensive yet lightweight, easy to navigate with a modern interface.

    Lise V.
    Quality Manager — G2 verified review

    The most helpful feature is the event capture option. Every time we get a data point, the app makes it easy to capture it and assign it to someone so it can be dealt with properly.

    Jeorge G.
    Microbiologist — G2 verified review

    Customer impact

    From spreadsheet chaos to continuous traceability

    Medical device companies often arrive at qmsWrapper after struggling with fragmented systems:

    • traceability maintained in spreadsheets
    • risk management disconnected from development
    • audits requiring months of preparation

    After implementing qmsWrapper:

    • traceability maintenance reduced by over 80%
    • risk management integrated with design controls
    • audit preparation significantly simplified Teams spend less time maintaining the system and more time building better medical devices..

    Your Quality System Should Work for You, and not the other way around.

    Stop maintaining your QMS manually.

    Let qmsWrapper maintain it for you.

    Discover how an Integrated AI quality management system can transform your quality operations.

    Before you Choose

    Schedule Your Personalized qmsWrapper Demo

    See how a Medical Device QMS works in real regulatory scenarios.

    Key Questions Before Choosing a QMS

    How is qmsWrapper different from traditional QMS platforms?

    Traditional QMS platforms are built around documents, requiring teams to manually maintain traceability, risk files, and quality records, often across spreadsheets, logs, and disconnected systems.

    This typically includes:

    • traceability matrices in Excel
    • change logs n Excel, supplier lists, and customer records
    • CAPAs, nonconformities, and quality events tracked separately

    qmsWrapper is built as a process-based, integrated AI system where documents, risks, requirements, CAPAs, and changes are continuously connected through an integrated traceability structure. Instead of maintaining spreadsheets and manually updating records, the system maintains these relationships automatically in real time, reducing overhead and improving consistency across all quality data.

    Can AI really be trusted in a regulated quality system?

    Yes, because AI in qmsWrapper is designed to assist, not replace, human responsibility.

    AI supports tasks like traceability updates, risk analysis, and form completion, but:

    • all outputs remain fully reviewable and editable
    • approvals and final decisions stay with your team
    • every action is recorded with a complete audit trail

    This ensures compliance while significantly reducing manual workload.

    How long does it take to implement qmsWrapper?

    Most organizations are operational within approximately one week.

    qmsWrapper is delivered with an ISO 13485-aligned structure and prebuilt workflows, so there is no need for long configuration or external consultancy projects.

    Teams can start using the system quickly and adapt it as they grow.

    Is qmsWrapper compliant with FDA, ISO, and global regulations?

    Yes. qmsWrapper is designed to support compliance with major regulatory frameworks, including:

    • FDA QMSR (21 CFR Part 820, effective 2026-02-02)
    • 21 CFR Part 11 (electronic records and signatures)
    • ISO 13485 and ISO 9001
    • ISO 14971 (risk management)
    • EU MDR / IVDR and UKCA
    • 510(k) submission support
    • GDPR and HIPAA

    The system maintains full traceability, audit trails, and structured records required for regulated environments.

    Will the system force us into rigid workflows?

    No, qmsWrapper is designed to adapt to your processes.

    Unlike traditional QMS platforms that require heavy configuration or fixed templates, qmsWrapper allows you to:

    • configure workflows and approvals
    • build custom forms and modules
    • evolve your processes as your organization grows

    Your quality system remains structured, but flexible.

    What happens to our existing documents and processes?

    Existing documentation and processes can be migrated into qmsWrapper and connected within the system.

    Instead of remaining as isolated files, they become part of an integrated structure where traceability, risk, and quality events are continuously maintained.

    This allows teams to transition without losing previous work while significantly improving system organization.

    Can qmsWrapper scale with our company?

    Yes. The platform is designed to scale with:

    • growing teams
    • increasing document volume
    • expanding regulatory requirements

    The underlying structure remains stable, so you don’t need to redesign your system as your company evolves.

    What happens during a demo?

    The demo is tailored to your workflows and quality processes

    We’ll walk through how qmsWrapper manages documents, records, traceability, risk, CAPAs, quality events in a real system environment, using practical examples that reflect how your team works.

    There is no generic sales presentation: We can explore your own scenarios and show how they would run inside the system.

    You’ll see how traceability is maintained automatically and how your QMS can operate as a fully connected, continuously audit-ready system.

    How is qmsWrapper priced and what ROI can we expect?

    qmsWrapper is priced as a complete, fully integrated platform, with plans based on team size.

    All core functionality (traceability, risk management, CAPA, AI-assisted workflows) is included, with no separate modules or hidden costs.

    Teams typically reduce manual traceability maintenance by over 80%, while significantly decreasing audit preparation time and system maintenance.

    The model scales with your organization and delivers more value with less operational overhead. → Time saved, audit readiness, reduced overhead.