• 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

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    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.

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    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.

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    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.

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    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.

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    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 Bundles

    Select a subscription plan tailored to your organization

    Concept Bundle

    Develop a proof of concept

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    Document Control

     

    Architecture & Design

     

    Product Development Lifecycle

     

    Risk Management

     

    Management Responsibility

     

    Realization Bundle

    Design your product

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    Everything in Concept Bundle

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    Applicable Standards

     

    Design Verification

     

    Purchasing

     

    Supplier Management

     

    Facility Management & Infrastructure

     

    Human Resources

    Pilot Bundle

    Manufacture for compliance testing

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    Everything in Realization Bundle

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    Design Validation

     

    Change Control

     

    Audit

     

    Equipment

     

    Training

     

    CAPA

     

    Non-Conformng Products

     

    Receiving & Incoming Inspection

     

    DHF, DMR & Technical File

    Commercial Bundle

    Launch your product

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    Everything in Pilot Bundle

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    DHR

     

    Pre/Post-Market Surveillance

     

    Order Management

     

    Problem Reporting & Submission

     

    Recalls & Advisory Notes

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    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.