Frequently asked questions?

Yes. Every organization can explore QraOne with a complimentary 14-day trial. If you need additional time to complete your evaluation, we're happy to extend your trial upon request.

Pricing depends on team size and plan. Book a demo and we will give you a number in that call rather than after three follow-ups.

Yes. QraOne AI is included in every subscription by default, with no additional subscription fee or usage charges. Your team remains responsible for reviewing and approving AI-assisted outputs.

Absolutely. QraOne was designed to make enterprise-quality software accessible to startups and growing healthcare companies. You get the same powerful eQMS used by larger organizations - without unnecessary complexity or an enterprise-only approach.

The system is built around the requirements of:

• ISO 13485:2016
• FDA QMSR (21 CFR Part 820) and 21 CFR Part 11
• EU MDR 2017/745 and EU IVDR 2017/746
• ISO 14971 and IEC 62304
• ISO 9001 and ISO 27001-aligned controls

Yes. Every subscription includes free migration assistance to help you transition from your existing Quality Management System. Our team works with you to make the migration as smooth as possible.

Yes. Every QraOne subscription includes free onboarding to help your team get up and running quickly. Additional implementation services are available for organizations with more advanced requirements.

You export them. Documents, metadata and the audit trail come out in a structured format, at any time, not only at renewal. Your quality records are yours and we do not treat export as a retention lever.

QraOne currently supports integrations with GitHub, GitLab and Jira within the Quality Processes and Design Control modules. GitHub and GitLab can help connect relevant software development activity with design and quality records, while Jira can be used to link selected quality or design activities with issue and project tracking. Additional integrations may be considered based on your organisation’s specific requirements, technical setup and use case, subject to assessment by the QraOne team.

Yes. QraOne is a secure, cloud-based platform designed to protect your quality and regulatory data. We continuously improve the platform to maintain high standards of security, reliability and performance.

QraOne combines enterprise-quality capabilities with practical regulatory expertise. Unlike many platforms built primarily by software companies, QraOne was created by QA/RA professionals who understand how regulated healthcare companies actually work. The result is an intuitive, connected Quality Management System designed to simplify compliance - not complicate it.