Fact sheet · Compliance & audits
Qualio
AI compliance platform for life sciences that automates quality workflows and regulatory monitoring
Cloud-based AI compliance platform combining quality management systems with automated regulatory monitoring across 28+ frameworks for life sciences companies.
Overview
Qualio is an AI compliance platform purpose-built for life sciences companies. It combines a cloud-based quality management system with Compliance Intelligence, which uses AI agents to continuously monitor regulatory changes across FDA, ISO, EU MDR, and 28+ other frameworks. The platform automates gap analysis, maps evidence across submissions, and executes quality workflows to replace manual compliance labor. It serves medical device, pharmaceutical, biotech, software as medical device, cannabis, and contract research organizations.
Feature facts
- Document Control
- Training Management
- Supplier Quality Management
- CAPA Management
- AI-powered Gap Analysis
- Compliance Intelligence with AI agents
- Risk Management
- Design Control Management
- Change Control Management
- Audit Management
Pricing
Pricing model: Contact for pricing
Foundation plan available; Growth plan available; Scale plan custom pricing. Annual recurring subscription model. All plans include cloud storage and platform updates.
Follow Qualio: their milestones, new launches and awards come to you by email, once a day by default.
Qualio specifications
| Section | Compliance & audits |
|---|---|
| Origin | Dublin, Ireland |
| Website | qualio.com |
| Makers | Robert Fenton (Founder & CEO) |
| Votes2 | 0 |
Qualio metrics
| Metric | Value |
|---|---|
| Domain Rating | 61 +1 (up) since last check |
| Trust Flow | 24 no change since last check |
| Citation Flow | 42 no change since last check |
| Referring domains | 834 no change since last check |
| External backlinks | 40,486 no change since last check |
Fact: Ahrefs Domain Rating checked 12 Nov 2026, fact changed 31 Oct 2026. Fact: top topic Computers/Software/Internet (22). Fact: Majestic checked 25 Oct 2026, fact changed 25 Oct 2026. Link facts from Majestic. Trust Flow, Citation Flow and Topical Trust Flow are trademarks of Majestic-12 Ltd.
Qualio domain fact sheet
Open the fact sheet
| Domain age | 24 years |
|---|---|
| Registered | |
| Expires | |
| Registrar | NameCheap, Inc. |
| DNSSEC | Not signed |
Qualio launch receipt sheet
What we have measured for Qualio since it went live on SaaS Directory Info on 25 October 2026.
- 61 Domain Rating (Ahrefs) no change since launch
at launch: 61 (25 Oct 2026); latest: 11 Nov 2026 - 24 Trust Flow (Majestic)
first measured 25 Oct 2026 - 834 Referring domains (Majestic)
first measured 25 Oct 2026
Day 17 since launch. Next receipt: day 30, 24 Nov 2026. The figures report a change; they do not say what caused it, and many things can. No figure here is a guess.
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Frequently looked up
- Q1What is Qualio?
- Qualio is an AI compliance platform purpose-built for life sciences that combines a cloud-based quality management system with Compliance Intelligence, which uses AI agents to continuously monitor regulatory changes across FDA, ISO, EU MDR, and 28+ other frameworks, automatically running impact assessments and executing quality workflows.
- Q2What compliance frameworks does Qualio support?
- Qualio supports 28+ compliance frameworks including ISO 13485, FDA 21 CFR Part 820 (QMSR), EU MDR/IVDR, FDA 21 CFR Part 11, GxP, ICH, MDSAP, ISO 42001, IEC 62304, ISO 14971, and more. Custom frameworks can also be configured.
- Q3How long does implementation take?
- With proper preparation from your team, most customers go live within 30 to 60 days. Qualio's onboarding team consists of industry experts who guide you through every step.
- Q4Is Qualio priced as a one-off or recurring cost?
- Qualio is a cloud-based software provider that offers an annual recurring subscription model. The subscription includes all platform updates, cloud storage, and support with no hidden fees.
- Q5What industries does Qualio serve?
- Qualio serves medical device companies, pharmaceutical and biotech organizations, contract research organizations (CROs), software as a medical device (SaMD) companies, and cosmetics manufacturers from startups through mid-market and enterprise.
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Qualio has a free listing. The owner can unlock the full profile with a paid launch for $5:
- Founder story (locked)
- Milestones (locked)
- Demo video (locked)
- Dofollow website link (locked)
See also
| Product | Origin | DR1 | Votes2 |
|---|---|---|---|
| VereefyEU AI Act compliance platform for regulated companies | Switzerland | 0 | 0 votes. Log in to vote for Vereefy in the file |
| GMPSignalFDA warning-letter and enforcement intelligence delivered as a daily brief | not stated | 0 | 0 votes. Log in to vote for GMPSignal in the file |
 AnalyticsProofDaily journey replay and compliance monitoring for analytics tracking | Czech Republic | 2 | 0 votes. Log in to vote for AnalyticsProof in the file |
 SetLatchPrivacy requests, handled for every client site | Australia | 1 | 0 votes. Log in to vote for SetLatch in the file |