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.
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 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 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 - coming soon
Qity's Biobank is an affordable digital Biobank solution for Biotech organizations, that integrates with Qity iQMS.
Qity MES - coming soon
Qity's Manufacturing Execution System enables error-free, paperless manufacturing, in compliance with cGMP, ISO 13485 and 21 CRF Part 11.
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
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.