• 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

    Concept Bundle

    Develop a proof of concept

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    Core

    Document Control

    Design Control

    Product Lifecycle

    Risk

    Regulations & Standards

    Usability

    Governance

    Realization Bundle

    Design your product

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    Everything in Concept Bundle

    +

    Purchasing

    Equipment & Tools

    Supplier

    Facility & Infrastructure

    Competence & Training

    Bill of Materials

    Pilot Bundle

    Manufacture for compliance testing

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    Everything in Realization Bundle

    +

    Change Control

    Audit

    CAPA

    Nonconformity

    Deviation

    Derogation

    Inventory

    Manufacturing

    Commercial Bundle

    Launch your product

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    Everything in Pilot Bundle

    +

    Market Surveillance

    Order Processing

    Customer Service

    Submission

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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.