Qualio
Qualio is a quality management and compliance platform built exclusively for life sciences companies. It helps medical device, pharmaceutical, biotech, and digital health organizations accelerate regulatory approvals, stay audit-ready, and scale compliance operations without adding headcount. Our platform manages the full range of quality processes, including document control, training, CAPA, change control, supplier management, risk management, and design controls, all in one validated system, supporting FDA 21 CFR Part 11, ISO 13485, EU MDR, MDSAP, GxP, ICH Q10, and other life sciences requirements. Move faster without compliance as the bottleneck. Qualio connects regulatory affairs, quality, and R&D in one platform, with deep integrations into Jira, Azure DevOps, GitHub, Salesforce, and other tools teams already use, removing the handoffs and manual documentation that typically slow product development down. Get to market faster. Automated gap analysis and multi-framework compliance mapping cut audit preparation time by 80%. Reusing evidence across FDA, ISO, and EU submissions has helped customers shrink market entry timelines from 9 months to 3-4 months, while cross-mapped documentation accelerates 510(k) submissions, CE marking, and international expansion. Scale without growing your compliance overhead. Customers report a 99% reduction in quality administrative time and have eliminated $150K-$300K in annual consulting costs by replacing manual processes, driving 5X ROI within 2 months. See risk before it becomes a finding. End-to-end traceability connects requirements, risk assessments, CAPAs, and product changes, with risk-based alerting that flags gaps before they turn into FDA 483 observations, warning letters, or audit findings. Customers have passed ISO 13485 certifications and sponsor audits with zero major nonconformances using this always-on monitoring. Qualio serves life sciences companies from pre-market startups to established enterprises, with the SOC 2, HIPAA, and pharmacovigilance capabilities growth-stage companies need, deploying faster than legacy eQMS vendors while maintaining the validation rigor required for FDA inspections and notified body audits.
Average Rating: 4.4/5.0
Total Reviews: 775
How Do G2 Users Rate Qualio?
- Has the product been a good partner in doing business?: 9.1/10 (Category avg: 9.3/10)
- Ease of Use: 9.0/10 (Category avg: 8.9/10)
- Ease of Admin: 8.9/10 (Category avg: 8.7/10)
- Ease of Setup: 8.8/10 (Category avg: 8.6/10)
Who Is the Company Behind Qualio?
- Seller: Qualio
- Company Website:
- Year Founded: 2012
- HQ Location: San Francisco, California
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Twitter: @qualiohq
711 Twitter followers -
LinkedIn® Page: www.linkedin.com
124 employees on LinkedIn®
Who Uses This Product?
- Who Uses This: Quality Manager, Clinical Data Associate
- Top Industries: Medical Devices, Pharmaceuticals
- Company Size: 52% Medium, 40% Small
What Do G2 Reviewers Say About Qualio?
AI-generated summary from verified user reviews
Pros
- Users find Qualio to be incredibly easy to use, enhancing the training experience with its intuitive interface.
- Users appreciate the user-friendly training modules of Qualio, which enhance efficiency and simplify tracking training progress.
- Users value the extremely searchable document management system in Qualio, enhancing control and ease of use.
- Users appreciate the efficient document control of Qualio, enhancing organization and simplifying the approval process.
- Users love Qualio's intuitive interface, making it easy to navigate, learn, and improve collaboration effectively.
Cons
- Users find document update triggers problematic due to multiple change requests, creating complexity in document management.
- Users express frustration over feature limitations in Qualio, affecting access, updates, and overall experience.
- Users find difficult usability in Qualio, particularly with editing older document versions and feedback on answers.
- Users find Qualio's interface not user-friendly, citing rigidity and limited customization options that hinder their experience.
- Users face editing difficulties with table formatting and lack timely notifications for overdue document reviews in Qualio.
What Are Recent G2 Reviews of Qualio?
"Helpful QMS Platform for Daily Operations"
Rating: 4.5/5.0 stars
— Divyanshu R.
"It makes my onboarding life easier"
Rating: 4.5/5.0 stars
— Marta G.
What Are G2 Users Discussing About Qualio?
- What is Qualio used for? - 1 comment, 1 upvote
- What does Qualio do? - 6 comments, 5 upvotes
- What is Eqms quality management system? - 2 comments, 1 upvote
- What is QMS software? - 2 comments, 1 upvote
- What is Qualio? - 3 comments, 2 upvotes

