Qualio doesn’t publish prices. Its pricing page lists three plans and asks you to “talk to us for a quote”, and it says an implementation fee applies to all plans.1 Our figure for a 10-person team is an estimate, built from Qualio’s own old price lists and two independent signals.
Plans and what they include
Qualio’s pricing page (checked September 2026) lists three plans:1
- Foundation: 5 edit users, unlimited read-only users, 3 compliance frameworks, and quality events limited to 5 templates.
- Growth: 10 edit users, unlimited read-only users, 5 frameworks, unlimited quality events and the developer API.
- Scale: custom pricing for multi-site operations.
Both standard plans include document control, training, supplier quality, design controls and reporting.1 SSO, OneDrive and Jira are included at no extra cost.1 Qualio sells the subscription on an annual recurring model.1
Fees on top
- Implementation. Required on every plan; the amount isn’t published.1 Archived versions of the pricing page said all new customers had to buy onboarding services, until at least 2022.2
- Extra edit users. Charged as an additional fee, with no published rate.1
- Integration Hub. Needed for GitHub, GitLab and Azure DevOps.1
- Content Pathways. Qualio’s SOP templates are a paid add-on.1
- Extra frameworks and extra instances. Also charged on top.1
The validation pack provides a validation plan, a summary report and a Part 11 assessment. Qualio doesn’t say whether it costs extra.3
How we got the estimate
Qualio published prices until 2021. Archived copies of its pricing page show:
- January 2019: Starter from $850 a month, Growth from $2,500 a month and Enterprise from $7,500 a month, billed annually.4
- August 2020: annual plans from $12,000.5
- January 2021: annual plans from $14,000. The starter plan then lacked quality events.6
Two independent sources add to that. SoftwareConnect lists about $3,000 per user on top of the base price, without giving a basis.7 MedDeviceGuide estimates $5,000–15,000 a year for small teams, also without a basis.8 That is below every price Qualio has published, so we treat it as an outlier.
Our range of $12,000–30,000 a year runs from the last published starting prices ($12,000–14,000 in 2020 and 2021) to the 2019 Growth plan at $30,000 a year.456 Vendr, a price benchmark, has no data on Qualio.9
What a 10-person team pays
A team of 10 fits Foundation if only five people edit documents, or Growth if all 10 do, since read-only users are unlimited on both.1 Expect to pay inside our $12,000–30,000 range, plus the implementation fee in the first year. If you need GitHub or Azure DevOps links or SOP templates, add the Integration Hub and Content Pathways.1
Applied to SoftwareConnect’s base price, its per-user figure would give about $27,000 a year for 5 edit users and $42,000 for 10. It has no stated basis, so it doesn’t set our range.7
Price history and renewals
- List prices. The starting price rose from $12,000 (August 2020) to $14,000 (January 2021), about 17%.56 Qualio has published no prices since, so there is no recent history to check.1
- Renewal increases. The terms let Qualio set a new subscription fee for each renewal term after advance notice, with no cap or index.10 Your only option is to give 30 days’ notice before the term ends and leave.10
- User reports. In April 2024 one Capterra reviewer reported a price increase in the past year that Qualio wouldn’t negotiate or justify.11
Contract length and leaving
Qualio’s terms leave the term to each order form, and its pricing page describes an annual subscription.101 Two competitor articles report three-year minimums; we couldn’t confirm that from a neutral source, so check your order form. Fees are non-cancellable and non-refundable, and you can’t reduce seats during a term.10
We found no exit fee in the terms. After termination you get 30 days to retrieve your data, but only if you ask in writing before the end date.10 Documented exports cover documents, training, events, suppliers and the audit trail, in PDF, Word, XLSX and CSV.1213
How Qualio compares on price
- Greenlight Guru publishes a starting price of $12,000 a year and also charges implementation separately. We estimate $12,000–30,000 a year for 10 people, the same range as Qualio, and Vendr reports deals from $20,975 to $54,739.1415
- SimplerQMS publishes $17,500 a year for up to 15 users, with implementation, validation, migration and training included. Its terms add 5% every 1 January.1617
- MasterControl costs more: we estimate $25,000–72,000 a year for 10 users, plus implementation.18
Qualio: Plans and pricing. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Qualio pricing page, archived 20 Jan 2022. Vendor website (Wayback Machine), checked 29 Sep 2026. ↩︎
Qualio Validation FAQ. Vendor help center, checked 29 Sep 2026. ↩︎
Qualio pricing page, archived 29 Jan 2019. Vendor website (Wayback Machine), checked 29 Sep 2026. ↩︎ ↩︎
Qualio pricing page, archived 4 Aug 2020. Vendor website (Wayback Machine), checked 29 Sep 2026. ↩︎ ↩︎ ↩︎
Qualio pricing page, archived 10 Jan 2021. Vendor website (Wayback Machine), checked 29 Sep 2026. ↩︎ ↩︎ ↩︎
SoftwareConnect: Qualio QMS pricing and reviews. Software directory, checked 29 Sep 2026. ↩︎ ↩︎
MedDeviceGuide: Best eQMS software for medical devices 2026. Independent buyer guide, 4 Apr 2026. ↩︎
Vendr: Qualio. Price benchmark, checked 29 Sep 2026. ↩︎
Qualio: Terms of Service. Vendor legal page (effective 13 Aug 2024), checked 1 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Qualio reviews on Capterra, page 3. Review site, checked 1 Oct 2026. ↩︎
Qualio Security Practices. Vendor help center, checked 29 Sep 2026. ↩︎
User Permissions. Vendor help center, checked 29 Sep 2026. ↩︎
Greenlight Guru: Quality pricing and packages. Vendor website, checked 29 Sep 2026. ↩︎
Vendr: Greenlight Guru pricing. Price benchmark, checked 29 Sep 2026. ↩︎
SimplerQMS: Pricing and licenses. Vendor website, checked 30 Sep 2026. ↩︎
SimplerQMS A/S: Terms and conditions. Vendor legal page, last updated 14 Oct 2024, checked 30 Sep 2026. ↩︎
Our MasterControl review, pricing section, checked 4 Oct 2026. ↩︎
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