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  • Services

    Qity's experts provide a range of services in Quality Assurance, Regulatory Affairs, Safety Testing, Architecture & Design, Cybersecurity & Data Privacy and Usability Engineering to organizations in the biotech, medical devices, in-vitro diagnostics, digital health and pharma industries.

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    Quality & Regulatory Affairs

    Quality Management System, audits, device classification, applicable standards and regulatory strategy

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    Safety Testing

    Electrical safety testing and troubleshooting in compliance with IEC 60601 or IEC 61010

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    Architecture & Design

    System, Hardware and Software Architectural Design, component and supplier selection, product roadmapping

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    Cybersecurity & Data Privacy

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

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    Usability Engineering

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

  • Products

    We have developed a series of software tools that facilitate product development, quality management, cybersecurity, and information security in regulated environments, so you can spend less time on paperwork and focus on developing your product.

    Qity iQMS

    Qity iQMS is a complete ecosystem for the development of medical devices, comprising a modular electronic Quality Management System, deeply integrated with Atlassian's industry-leading collaboration platform (Confluence & Jira) and your design and development tools, dramatically reducing regulatory overhead.

    Qity ISMS

    Qity ISMS is a complete Information Security (and Privacy) Management System, deeply integrated with Atlassian's industry-leading collaboration platform (Confluence & Jira) and Qity iQMS, and designed bottom-up to efficiently design, deploy, monitor, and trace compliance with the most stringent standards of Information Security and Data Privacy.

    Qity Biobank

    Qity's Biobank is an affordable digital Biobank solution for Biotech organizations, that integrates with Qity iQMS.

    Qity MES

    Qity's Manufacturing Execution System enables error-free, paperless manufacturing, in compliance with cGMP, ISO 13485 and 21 CRF Part 11.

  • Training

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    We provide comprehensive training on (medical) product development, including architecture, design, usability, and validation.

    Additionally, we offer training on tools and technologies, such as Jira and Confluence.

    Our team is also well-versed in regulatory standards and provides training to ensure compliance with FDA regulations and international standards.

     

    Contact us to learn how our training can equip your team with the necessary knowledge and skills for successful (medical) device development.

  • The Qity Difference

     

    Solution oriented

    Failed a safety test? A usability test? Compliance gap?

    Through years of experience and an in-depth understanding of your product design, our engineers will propose practical solutions to any identified gap or issue.

    Quality as part of Product Development

    We believe Quality should be an essential part of your product development lifecycle, intended to continuously improve the way you work and to effectively increase product quality while reducing the cost of non-quality.

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