
Lending a Hand to Life Science
Expert Services
Qity's experts provide a range of services in Quality Assurance, Regulatory Affairs, Clinical Research, EMC & 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
Clinical Research
Clinical program management: from idea and clinical strategy to pre-market and post-market study conduct.
EMC & Safety Testing
Electrical safety testing and troubleshooting in compliance with IEC 60601 or IEC 61010
Medical Device Development
Fast-track your medical device development through pre-tested, medical grade software and hardware building blocks.
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
Game-Changing Software Tools
Qity's user-friendly software products, designed for Atlassian's Confluence and Jira platform, digitize and streamline all processes within your organization, replacing disparate tools at a fraction of the cost.
Qity iQMS
Qity iQMS is a complete electronic Quality Management System for regulated industries.
Unlike traditional stand-alone systems, iQMS lives where the action is, where the team organizes their work.
By directly integrating with design, development and planning tools, it eliminates manual import and export of data between systems, dramatically reducing regulatory overhead.
Qity iMES
Qity's Manufacturing Execution System enables error-free, paperless manufacturing, in compliance with cGMP, ISO 13485 and 21 CRF Part 11.
Digital work instructions on industrial touch screens provide step-by-step guidance, registering every step of the process, including quality events, traceability and stock management.
iMES integrates seemlessly with iQMS, providing cockpit-views to Quality and Manufacturing teams.
Qity iSMS
Qity iSMS is a complete Information Security (and Privacy) Management System for Atlassian's Confluence & Jira.
Efficiently design, deploy, monitor, and trace compliance with the most stringent standards of Information Security and Data Privacy, such as ISO 27001, SOC2, NIS2 and GDPR.
iSMS integrates with iQMS, sharing modules such as Document Control, Change Control, Audit and Risk Management.
Certified Trainings
Qity provides 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 successfully bringing your product to market.
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.