Qity iQMS
Regulatory compliance, without the overhead
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.
