• 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.

    Quality & Regulatory Affairs

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

    Safety Testing

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

    Architecture & Design

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

    Cybersecurity & Data Privacy

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

    Usability Engineering

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

  • Software Tools

    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 - coming soon

    Qity ISMS is a complete Information Security Management System for Atlassian's industry-leading collaboration platform (Confluence & Jira).

    Qity Biobank - coming soon

    Qity Biobank is an affordable digital Biobank solution for Biotech organizations, based on Jira.

    Qity TestPilot - coming soon

    Qity TestPilot is a Python-based automated test system for manufacturing, integrated with Qity iQMS.

  • Training

    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.

    Terms & Conditions
    Welcome to Qity's website. If you continue to browse and use this website, you are agreeing to comply with and be bound by the following terms and conditions of use, which govern our relationship with you in relation to this website. If you disagree with any part of these terms and conditions, please do not use our website.
    The term 'Qity' or 'us' or 'we' refers to the owner of the website. The term 'you' refers to the user or viewer of our website.
    The content of the pages of this website is for your general information and use only. It is subject to change without notice.
    Neither we nor any third parties provide any warranty or guarantee as to the accuracy, timeliness, performance, completeness, or suitability of the information and materials found or offered on this website for any particular purpose. You acknowledge that such information and materials may contain inaccuracies or errors and we expressly exclude liability for any such inaccuracies or errors to the fullest extent permitted by law.
    Your use of any information or materials on this website is entirely at your own risk, for which we shall not be liable. It shall be your own responsibility to ensure that any products, services, or information available through this website meet your specific requirements.
    This website contains material which is owned by or licensed to us. This material includes, but is not limited to, the design, layout, look, appearance, and graphics. Reproduction is prohibited other than in accordance with the copyright notice, which forms part of these terms and conditions.
    All trademarks reproduced on this website, which are not the property of, or licensed to, the operator, are acknowledged on the website.
    Unauthorised use of this website may give rise to a claim for damages and/or be a criminal offense.
    From time to time, this website may also include links to other websites. These links are provided for your convenience to provide further information. They do not signify that we endorse the website(s). We have no responsibility for the content of the linked website(s).
    Your use of this website and any dispute arising out of such use of the website is subject to the laws of Belgium.
    Consultancy Services:
    We offer consultancy services to our clients. The nature and scope of these services will be agreed upon in writing by us and the client.
    We will use reasonable care and skill in providing the consultancy services to the client. However, we do not guarantee any particular result or outcome.
    Software Tools:
    We offer software tools for sale on this website. The purchase and use of these tools are subject to the terms and conditions set out in the relevant end-user license agreement.
    Contact Form:
    The use of the contact form on this website is subject to the following terms and conditions:
    a) The information you provide through the contact form will be used solely for the purpose of responding to your query or request.
    b) By submitting your query or request through the contact form, you consent to us contacting you in relation to that query or request.
    c) We reserve the right to refuse to respond to any query or request submitted through the contact form if we believe that it is spam, malicious, or otherwise inappropriate.
    We reserve the right to amend these terms and conditions at any time. Any such amendments will be effective from the date they are published on this website. Your continued use of this website following any such amendments will be deemed to be your acceptance of such amendments.