Qualio
Dublin-registered eQMS for medical device and life science teams that want document control, design controls and regulatory gap analysis in one subscription
Quick Overview
| Company | Everworks Limited (trading as Qualio) |
|---|---|
| Category | Quality Management Software (QMS) |
| Headquarters | Dublin, Ireland |
| Founded | Not stated |
| EU Presence | Yes - Ireland (EU) |
| Data Location | Not stated on the pages checked |
| Open Source | No |
| GDPR Compliant | Yes |
| Self-Hosting | No |
| Main Features | Document control, training management, supplier quality, quality events and CAPA, design controls, compliance frameworks (FDA, MDR, ISO, GxP), AI gap analysis, Jira and GitHub integrations |
| Pricing | Plans Foundation, Growth and Scale; no prices published, implementation fee applies |
| Best For | Venture-backed medtech and biotech teams moving from spreadsheets to a first audited QMS |
| Replaces | MasterControl, Veeva Vault QMS |
Detailed Review
Qualio sells a hosted quality system for companies that must show regulators how a product was designed, tested and released. The terms of service name Everworks Limited, trading as Qualio, as the contracting party, with a registered office on City Quay in Dublin.
Where MasterControl bundles quality with manufacturing execution, Qualio stays on the quality and product-development side, which keeps the scope narrower and the rollout shorter.
Plans built around editing seats
The pricing page splits users into editing users and unlimited basic users. Foundation includes 5 editing users and Growth includes 10, while Scale is quoted individually with multi-site and custom configuration.
The tiers also differ in how many compliance frameworks are included (3 on Foundation, 5 on Growth), with extra frameworks sold separately.
Framework mapping and AI assistance
Qualio maps existing documents to regulatory controls from FDA, MDR, ISO and GxP sets and runs a gap analysis against them. A Copilot drafts and reviews documents inside the quality workflows.
Continuous regulatory monitoring and automated evidence collection are listed on the Growth plan only.
Design controls next to the QMS
Design controls sit on the same platform as document control and CAPA, with an integration catalogue that includes Jira, GitHub, GitLab, Azure DevOps and TestRail. For a software-as-medical-device team this keeps engineering tickets and quality records linked.
Limitations to Consider
Prices are not published and an implementation fee is charged on every plan. The pages checked do not say where customer data is stored, and the messaging leans on FDA readiness more than on European notified-body practice. Manufacturing execution is outside its scope, so a plant that needs batch records should look at CAQ AG instead.
Who Should Use Qualio
Small to mid-sized medical device, SaMD and biotech companies in Europe that want a quality system for first audits without a manufacturing module.
Pros and Cons
Pros
- Contracting entity registered in Ireland
- Design controls and CAPA on one platform
- Maps documents to FDA, MDR, ISO and GxP controls
- Unlimited basic (read and sign) users
- Developer-tool integrations such as Jira and GitHub
Cons
- No public price list
- Implementation fee on every plan
- Data location not stated on the pages checked
- Extra frameworks cost more
Alternatives to Qualio
Other European quality management software (qms) worth comparing before you decide:
SimplerQMS
Denmark · Pre-validated eQMS from Copenhagen with a listed starter price
Scilife
Belgium · Brussels eQMS for pharma and medical devices with module tiers
OpenRegulatory (Formwork)
Germany · Low-cost eQMS and technical documentation for medical device startups
Cognidox
United Kingdom · Cambridge eQMS built on document control for device developers
See all European quality management software (qms) or compare them directly against MasterControl on our alternatives page.
Frequently Asked Questions
The terms of service name Everworks Limited, trading as Qualio, a company incorporated in Ireland with its registered office at 13-18 City Quay, Dublin.
No. The pricing page shows three plans and states that an implementation fee applies to all of them, with a quote on request.
It covers document control, training, supplier quality and CAPA, but the pages checked do not show manufacturing execution or batch records, so a plant with those needs should compare it with other options.