AI ENABLED
Where Compliance Meets Automation
A next-generation eQMS built for medical device, SaMD, pharmaceutical, and life sciences companies, designed to make compliance effortless, audits faster, and innovation unstoppable.
Compliance shouldn’t slow you down - it should accelerate your growth
QraOne transforms manual regulatory work into automated, audit-ready workflows.
45% automation-first workflows that eliminate repetitive tasks
Audit readiness in hours, not weeks
No more version chaos with real-time change control & traceability
Global regulatory alignment across FDA, EU MDR/IVDR, GCC, India, and APAC
Configurable modules that match your processes, not the other way around
Boost your productivity with smart compliance workflows
QraOne empowers medical device companies to achieve compliance faster and with fewer resources through streamlined automation.
70%
Reduction in document preparation time
85%
Faster regulatory submission
60%
Decrease in compliance-related costs
Traditional Process
- Manual document creation (3-5 days)
- Manual gap analysis (2-3 days)
- Manual risk assessment (4-7 days)
- Manual regulatory tracking (Ongoing)
Total Time:
9-15+ days
With QraOne
- Guided document creation (4-8 hours)
- Automated gap analysis (2-4 hours)
- Risk assessment support (1 day)
- Automated regulatory tracking (Real-time)
Total Time:
1.5-2 days
Core Modules
Document Control
Versioning, training linkage, e-signatures
Supplier Control
Audit, approval workflows & SCAR
Risk Management (ISO 14971)
AI-assisted risk estimation
Training Management
Auto-assign per roles/SOP changes
Design Control + DHF/DMR
Full technical file: MDR + FDA traceability matrices
QraOne AI
Automated documentation & regulatory gap reports
Quality Events (CAPA/NC/ Deviation/SCAR/Change/Audit/ Management Review)
Smart investigations + root-cause
Who we are
QraOne supports companies working with global medical regulations
Designed for innovators who need compliance to scale globally and locally.
Frequently Asked Questions
Everything you need to know about QraOne and eQMS compliance.
An eQMS (electronic Quality Management System) is software that digitizes the processes a regulated company uses to manage quality — documents, SOPs, CAPAs, audits, training records, and risk files — replacing paper-based or spreadsheet QMS systems. For medical device and life sciences companies, an eQMS helps demonstrate compliance with standards such as ISO 13485 and FDA regulations.
Yes. QraOne supports the FDA's Quality System Regulation (21 CFR Part 820) requirements, helping medical device companies structure their documentation, design controls, and quality processes to streamline the path to FDA clearance and approval.
Yes. QraOne is designed around ISO 13485:2016 quality management requirements, enabling medical device companies to build, maintain, and demonstrate a certifiable QMS.
Yes. QraOne supports companies working under global medical regulations, including EU MDR and IVDR, alongside FDA and ISO frameworks — useful for manufacturers selling into multiple markets.
QraOne is used by medical device manufacturers (Class I–III), SaMD and AI-based healthcare companies, IVD and diagnostics firms, pharmaceutical and biotech teams, and startups entering regulated markets that need a compliant QMS without heavy administrative overhead.
You can book a personalized demo and our team will walk you through the platform using scenarios from your own regulatory context. Visit the Book a Demo page to schedule a session.
We empower growth with compliant innovation
At ComplianceMedQRA, we believe compliance should accelerate innovation - not restrict it.
QraOne embodies that mission by providing:
Simpler compliance
Faster market approvals
Continuous regulatory confidence
AI-powered future readiness
Ready to simplify compliance
and accelerate approvals?
Let QraOne transform how your organization manages quality
support@qraone.com