# QraOne

> QraOne is an electronic quality management system (eQMS) for regulated
> healthcare and life sciences teams — medical devices, SaMD, IVD, pharma and
> biotech. It brings document control, quality processes, training, supplier
> management, design control and AI assistance into one platform.

Built by Compliance MedQRA FZCO, a QA/RA consultancy based in Dubai, United Arab Emirates.
The people who build the software are the people who do the regulatory work,
which is where the platform's assumptions come from.

## Key facts

- Product: QraOne eQMS, cloud-based, browser-delivered
- Built for: ISO 13485, FDA QMSR (21 CFR Part 820), 21 CFR Part 11, EU MDR 2017/745, EU IVDR 2017/746, UAE EDE registration
- AI: QraOne AI is included in every plan at no extra subscription or usage charge. Human review and approval are mandatory before anything enters a controlled record.
- Plans: Startup, Growth, Enterprise. Pricing is quote-based; free migration and onboarding are included in every plan.
- Trial: 14-day complimentary trial, extendable on request.

## Core pages

- [Home](https://qraone.com/): what QraOne is and who it is for.
- [QraOne Platform](https://qraone.com/platform): all nine modules and how they connect.
- [Plans](https://qraone.com/plans): Startup, Growth and Enterprise tiers.
- [QA/RA consulting](https://qraone.com/consulting): regulatory strategy, submissions, QMS and audit support.
- [Resources](https://qraone.com/resources): hub for the blog and FAQ.
- [Blog](https://qraone.com/blog): quality and regulatory writing by QA/RA experts.
- [FAQ](https://qraone.com/faq): trials, pricing, frameworks, migration, security.
- [About](https://qraone.com/about): the team behind QraOne.
- [Contact](https://qraone.com/contact): request a trial or book a demo.

## Modules

- [Document Control Software](https://qraone.com/platform/document-control): Manage SOPs, policies, work instructions and forms through their full lifecycle: version control, review and approval, change history and AI-assisted drafting.
- [CAPA & Quality Process Software](https://qraone.com/platform/quality-processes): Manage CAPA, nonconformities, change control, complaints and audit findings through structured, traceable workflows, with AI-assisted investigation support.
- [Training Management Software](https://qraone.com/platform/training): Connect training to controlled SOPs, plan annual and event-driven programmes, track completion and overdue items, and keep traceable training records.
- [Supplier Management Software](https://qraone.com/platform/supplier-quality): Maintain a central supplier register with qualification, classification, approvals, required records and scheduled re-evaluation.
- [Design Control Software](https://qraone.com/platform/design-control): Connect design inputs, outputs, risks and verification evidence across the product lifecycle, with design reviews and lifecycle traceability.

## Contact

- Email: support@qraone.com
- Phone: +971 52 299 5578
- Address: Building A1, Dubai Digital Park, Dubai Silicon Oasis, Dubai, United Arab Emirates