Qualio review

About the price: Estimate for a 10-person team, Sep 2026, based on Qualio's own archived list prices (2019–2021) and two independent signals. Not published today. Mandatory implementation fee extra; amount unconfirmed.

What is Qualio?

Qualio is a cloud eQMS for life sciences companies, headquartered in San Francisco.¹ Its homepage claims 500+ customers in 80+ countries.²

Medical devices are one of several target markets, alongside pharma and biotech.³ Since October 2025, Qualio has sold AI gap analysis against FDA QMSR, ISO 13485 and MDSAP.⁴ The core product covers:

• documents, training and change control
• suppliers and audits
• design controls and risk
• a configurable “Events” module for CAPAs, nonconformances and complaints⁵⁶

Who Qualio is for

Qualio fits a device company of roughly 10 to 50 people that wants a system non-quality staff will adopt and prefers a guided rollout. Reviewers rate it highly for ease of use,⁷ and onboarding follows an eight-week program with a dedicated onboarding manager.⁸ It also suits companies that make both devices and drug or biologic products, since deviations, OOS and pharmacovigilance sit in the same platform.⁹

Look elsewhere if:

• You’re a very small team on a tight budget. Past list prices started at $12,000 a year before implementation fees.¹⁰
• You need dedicated DHR, UDI or complaint-to-MDR workflows. We found none in Qualio’s documentation, only SOP templates.¹¹
• You’re a software team that needs IEC 62304 tooling beyond generic design controls.¹²

Qualio pricing

Qualio doesn’t publish prices.³ Its pricing page (checked September 2026) lists three plans:³

• Foundation: 5 edit users, unlimited read-only users, 3 compliance frameworks, quality events limited to 5 templates.
• Growth: 10 edit users, unlimited read-only users, 5 frameworks, unlimited events, developer API.
• Scale: custom pricing for multi-site operations.

Every plan carries an implementation fee, and the fee isn’t published.³ These cost extra:³

• extra edit users
• the Integration Hub, needed for GitHub, GitLab and Azure DevOps
• Content Pathways SOP templates
• extra frameworks and extra instances

Archived versions of the pricing page show past prices:

• January 2019: Starter from $850 a month, Growth from $2,500 a month and Enterprise from $7,500 a month, billed annually.¹³
• August 2020: annual plans from $12,000.¹⁰
• January 2021: annual plans from $14,000.¹⁴
• Until at least 2022: the FAQ said every new customer had to buy onboarding services.¹⁵

Our estimate of $12k–30k a year for a 10-person team uses those dated list prices and two independent signals:

• SoftwareConnect lists about $3,000 per user on top of the base price.¹⁶
• MedDeviceGuide estimates $5k–15k a year for small teams, without giving a basis.¹⁷ That’s below every price Qualio has published.

Features

Document control, records and change control

Documents go through review and approval with automatic versions and an immutable audit trail.¹⁸ You can search the audit trail and export it to CSV.¹⁹ Several people can edit a document at the same time.²⁰

If you prefer Word, you can edit files in OneDrive and fetch the changes back into Qualio, but you need a Microsoft OneDrive account.²¹ Google Docs files must be converted to Word first.²²

Change control is documented in detail:²³²⁴

• a change control tab on every document
• bulk document change requests
• change-request events
• configurable change control templates

The e-signature is your email plus password.²⁵ The validation pack includes a Part 11 assessment.²⁶

Design controls and risk

Both standard plans include design controls.³ They support up to three requirement levels with verification and validation test cases.¹² A design change control review generates trace matrices and change history logs.²³

Risk management is built on ISO 14971,¹² with FMEA and acceptability matrices.²⁷ Jira is included; GitHub, GitLab, Azure DevOps and other developer tools come with the Integration Hub add-on.³

CAPA, nonconformances and complaints

These run in the Events module, where you design templates with steps, owners and due dates.⁶ The help center documents the CAPA workflow, including effectiveness checks and reopening a CAPA if the check fails.²⁸ Event analytics track root cause, product and cycle time.²⁹

For nonconformances, the documentation only shows that they can be tracked as events, not an NC-specific workflow.²⁹ Complaints appear only as an example template,⁶ with intake from tools like Intercom through integrations.³⁰ We found no FDA MDR or EU vigilance reporting, and no UDI management; these exist only as SOP templates.¹¹

Training, suppliers and audits

Training can be assigned by role,³¹ and trainees must pass multiple-choice assessments with 100% before signing off.³² The supplier module has:

• supplier policies
• risk categories
• an exportable approved supplier list
• supplier analytics³³³⁴

Audits use templates for an audit schedule and audit files. Qualio links a recorded webinar it says demonstrates the workflow, but we couldn’t check the video.³⁵

Software development (IEC 62304)

The SaMD offering builds on design controls and developer-tool sync.³⁶ The design controls documentation doesn’t cover software safety classes, software items or SOUP lists.¹²

What users say

On G2, Qualio scores 4.4/5 from 781 reviews. It gets 9.0/10 for ease of use (663 ratings) and 9.1/10 for quality of support (561 ratings), as of 29 September 2026.⁷ On Capterra it scores 4.6/5 from 138 reviews, with 4.5 for ease of use and 4.7 for customer service.³⁷

In a sample of 90 G2 reviews read in October 2026, 92% are labelled by G2 as invited on behalf of the vendor or incentivized, and most were posted in 2026.⁷ Because invited and burst reviews tend to skew positive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.

Recurring themes:

• Easy to learn. Reviewers repeatedly praise the intuitive, modern interface.³⁸³⁹
• Helpful support. Support is mostly described as responsive.³⁹ It runs on weekdays by chat and email.³
• Document editor. Several reviewers from device and biotech companies report that formatting, tables, landscape forms and change tracking are harder than in Word.³⁷³⁸³⁹
• Search. Several reviewers find search clunky, though one says it has improved.³⁷³⁸³⁹
• Rigid workflows and basic reporting. G2 reviewers report limited flexibility for non-standard processes and a need to export data for complex analytics.⁴⁰ A Capterra reviewer reports the same for reporting.³⁷

Outside the review sites we found no first-hand user accounts.⁴¹

Security, hosting and validation

Qualio’s data processing addendum lists active ISO/IEC 27001, 27701, ISO 9001 and ISO 42001 certifications.⁴² We found no mention of SOC 2.⁴³

The public subprocessor list names a single web-application host: AWS EU-WEST 1 in Dublin.⁴⁴ That points to EU hosting for all customers, although Qualio doesn’t state it per plan. The DPA uses standard contractual clauses.⁴² Many of the roughly 40 subprocessors are US-based.⁴⁴

Other security measures:

• nightly backups with 35-day retention⁴³
• an annual third-party penetration test⁴²
• a 99.9% uptime target in the SLA⁴⁵
• SSO with Entra ID, Google or Okta⁴⁶

Qualio follows FDA’s Computer Software Assurance approach rather than IQ/OQ/PQ.⁴⁷ Its validation pack provides a default Validation Plan and Summary Report and a Part 11 assessment.²⁶ Support packs are added with each release.⁴⁸ Qualio doesn’t say whether the pack costs extra.

Buying and contract terms

• Try before you buy. There’s no free trial. You can click through an interactive product tour and request a demo.⁴⁹ The sandbox is for customers in implementation.⁵⁰
• Contract term. Qualio’s terms leave the term to each order form.⁵¹ Its pricing page describes an “annual recurring subscription model”,³ so we score the standard term as annual. Two competitor articles report three-year minimums, which we couldn’t confirm 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.⁵¹ If Qualio announces a price change for a renewal term, you can terminate with 30 days’ notice before your current term ends.⁵¹
• Data export. After termination you get up to 30 days to retrieve your data before it’s deleted.⁵¹ Documented exports cover documents, training, events, suppliers and the audit trail,⁴³ in PDF, Word, XLSX and CSV.⁵² Design-control data isn’t on that exit list, beyond the generated trace matrices.⁴³²³
• API. A public REST API with a developer portal is available on the Growth plan.⁵³³
• Time to go live. Qualio says most customers are live in 30 to 60 days,³ and it runs an eight-week onboarding program with a dedicated onboarding manager.⁸ SOP templates cost extra.³
• Price increases. The terms let Qualio set a new fee for each renewal term after notice, with no cap; your only option is to leave.⁵¹ With no list prices since 2021, there’s no recent price history to check.¹⁴ One Capterra reviewer reported a 2024 increase Qualio wouldn’t negotiate.³⁹ Ask for a renewal cap.
• If Qualio is sold or closes. The terms don’t promise data return or escrow if Qualio becomes insolvent or stops the service, and Qualio can transfer your contract to a buyer without your consent.⁵¹ At termination you only get the 30-day retrieval window if you ask for it in writing before the end date.⁵¹

Company and ownership

• Legal entity. Your contract is with Everworks Limited, trading as Qualio, an Irish private limited company (number 508152) registered in Dublin on 10 January 2012.⁵¹⁵⁴ Qualio, Inc., the US company that raised the venture funding, is incorporated in Delaware and based in San Francisco.⁵⁵
• Leadership. Qualio was founded in Dublin in 2012 and is still led by its founder.⁵⁶⁵⁷
• Ownership and funding. Privately held and venture-backed. Storm Ventures led an $11m Series A in 2020,⁵⁸ and Tiger Global and Menlo Ventures co-led a $50m Series B in 2021.¹⁵⁹ SEC filings show equity raises of $2.6m (2019), $11.0m (2020) and $50.0m (2021), and none since.⁵⁵ We found no acquisition or private-equity buyout.
• Accounts. The Irish company is current with its filings, with accounts to January 2025.⁵⁴ We couldn’t read the figures in its accounts.

Verdict

Qualio earns a 7.0. It pairs strong core document, training, supplier and CAPA workflows with real design controls, very good usability ratings, EU hosting and clean exit terms. Shortlist it if you’re a growing device or device-plus-pharma company that values adoption and guided onboarding. The main reasons to hesitate are pricing you can’t see before a sales call, a mandatory implementation fee, and thin support for complaint reporting, UDI and production records.

Visit the Qualio website (made by Qualio, Inc.)