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  • iQMS
  • Goodbye eQMS, hello iQMS
  • SME-Friendly
  • Atlassian Partner
  • Services
  • Our story
  • Contact us
  • …  
    • iQMS
    • Goodbye eQMS, hello iQMS
    • SME-Friendly
    • Atlassian Partner
    • Services
    • Our story
    • Contact us

     

     

     

     

    • iQMS
    • Goodbye eQMS, hello iQMS
    • SME-Friendly
    • Atlassian Partner
    • Services
    • Our story
    • Contact us
    • …  
      • iQMS
      • Goodbye eQMS, hello iQMS
      • SME-Friendly
      • Atlassian Partner
      • Services
      • Our story
      • Contact us
      • Qity iQMS

        Regulatory compliance, without the overhead

        Let's talk
      • Goodbye eQMS, hello iQMS !

        Qity iQMS is an Integrated Quality Management System for highly regulated industries..

        While a traditional eQMS is essentially an electronic version of the paper-based QMS, our iQMS is fully embedded in the tools you use every day to develop your product, effectively minimising the regulatory burden.

        Familiar tools, customised for compliance

        Built on Jira, Confluence, Bitbucket and Jenkins (used by 170,000+ companies), enriched with carefully selected apps, templates and automation scripts and configured for regulatory compliance.

        Integrated Document and Change Control

        Document Control and Change Control are exactly where they are supposed to be, the space where you write, collaborate and review your documents.

        No more manual imports and exports of documents into an external Document Control System.

        Manage your Technical File

        Documents are published to your Technical File upon release. Keep track of what was submitted to Notified Bodies. Show auditors the differences compared to previous submissions.

        Complete traceability and audit logs

        Who changed what, when?

        View resolved, rejected and unresolved review comments.

        Who approved or rejected a document, and why?

        Everything is logged. Any previous version can be restored.

        Automation, the future of regulatory product development

        Automatically run software or hardware tests with calibrated equipment or test your designs in modelling tools. Test reports are automatically generated.

      • Start-up and SME-friendly

        Grows with your organisation

        Tailored to the specific needs of your company, ensuring the right level of compliance at each stage of your product development.

        Cloud-based

        Low maintenance cloud infrastructure, in line with cybersecurity and data privacy regulations

        Affordable

        Customisation and services according to agreed Statement of Work.

        The deployed eQMS has an exceptionally low recurring cost.

      • 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.

      • Services

        Product Development

        System architecture, roadmapping, development and validation of complex, connected systems.

        Regulatory Affairs

        Device classification, identification of applicable standards and determination of regulatory strategy.

        Agile

        Certified agile coaches, SAFe, portfolio and project management with Jira.

        Usability Engineering

        From ideation, all the way to summative evaluation, in compliance with IEC-62366

        Cybersecurity

        Embed cybersecurity into your product development lifecycle, in compliance with MDCG 2019-16 and ISO-2700x

        Data Privacy

        HIPAA and GDPR compliance

      • Our story

        We spent a great deal of our career developing medical devices, for small and large companies, using traditional tools and electronic quality management systems.

         

        Unsatisfied by the capabilities of these tools, the overhead they induce, and lack of integration, we decided to develop a different and better eQMS. A system that connects to the development tools of the engineers and does some of the work for them, essentially lowering the regulatory burden and letting the team focus on developing their product.

         

      • Let's talk!

        We'd love to help turn your project into a success!

        Clé des Champs 20, Ohain, Belgium
        +32-484-189281
        +32-484-189281
        info@qity.be
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