• Goodbye eQMS, hello iQMS !


    Qity iQMS is not just an eQMS, but a complete ecosystem for Medical Device Development.


    Qity iQMS embeds a Quality Management System in the tools you use every day to develop your product and organize your work, effectively minimizing the paper work and regulatory burden.

  • Strengths

    Familiar tools, customised for compliance

    Built on Jira, Confluence, and Bitbucket (used by 170,000+ companies), enriched with Qity's innovative apps, templates, automation, specifically configured for regulatory compliance.

    Document Control in Confluence and Jira

    Say goodbye to importing/exporting documents into a separate Document Control System!

    Qity's compliant Document Control System is exactly where it is supposed to be: the space where you write, collaborate and review your documents.

    Grows with your organization

    Qity's modular iQMS is tailored to the specific needs of your company, ensuring the right level of compliance at each stage of your product development.


    Select the subscription plan tailored to your organization's needs.

    Automation, the future of regulatory product development

    Dramatically reduce turn-around time of quality activities, by automating software and hardware tests with calibrated equipment, and testing your designs using modelling and simulation tools. Documentation (e.g. test reports) is automatically generated in the Quality Management System.

    Complete traceability and audit trail

    Unparalleled control and traceability, offering comprehensive compliant audit trail, full change tracking, detailed review commentary, for ultimate accountability and continuous audit-readiness.

  • iQMS Plans

    Select a plan that is tailored to your organization

    Foundation Plan

    Develop a proof of concept

    Document Control


    Architecture & Design


    Product Development Lifecycle


    Risk Management


    Management Responsibility


    Prototyping Plan

    Design your product

    Everything in Foundation Plan



    Design Verification




    Supplier Management


    Facility Management & Infrastructure


    Human Resources

    Pilot Plan

    Manufacture for compliance testing

    Everything in Prototype Plan



    Design Validation


    Change Control










    Non-Conformng Products


    Receiving & Incoming Inspection


    DHF, DMR & Technical File

    Commercial Plan

    Launch your product

    Everything in Pilot Plan





    Pre/Post-Market Surveillance


    Order Management


    Problem Reporting & Submission


    Recalls & Advisory Notes

  • Global Atlassian Partner

    As a global Atlassian Partner, we are qualified to set up and maintain your platform.


    We stay on top of the latest developments from Atlassian and evaluate everything in-house before deploying to a customer.