CompareCognidox vs Qualio

Cognidox vs Qualio: price, contract and features compared

Compare with .

Cognidox

Higher score 7.2 / 10
Price Published

from $8k/yr

£6,000/yr for 5 users; 10 users need the unpriced Growth tier

Choose it if: You run a small or mid-sized device company, want strong document control with Part 11 e-signatures at a low price, and are happy to shape your own CAPA, change and supplier forms.

Watch out: Complaints, supplier, audit and design controls are thinly documented and largely document- or form-based, and the validation pack, SSO and the LMS cost extra below the higher tiers.

Qualio

Our score 6.8 / 10
Price Estimate

est. $12–30k/yr

Estimate from 2019–2021 list prices; implementation fee extra

Choose it if: You're a growing device or combined device-and-pharma company that wants a QMS your whole team will actually use, with design controls linked to Jira and data hosted in the EU.

Watch out: Prices aren't published, every plan carries an implementation fee, and complaint handling, vigilance reporting and production records aren't dedicated features.

Placeholder data: some scores, prices and features on this page have not been verified yet.

Side by side

Cognidox 7.2Qualio 6.8
Price and buying
AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees.8.5 from $8k/yr £6,000/yr for 5 users; 10 users need the unpriced Growth tier5.5 est. $12–30k/yr Estimate from 2019–2021 list prices; implementation fee extra
Price transparencyHow we score price transparencyWhether the vendor publishes its prices on its own website.6.0 Starting price only Tier limits published; add-ons and services unpriced2.0 No public prices Published until 2021; implementation fee not published
Try before you buyHow we score try before you buyWhether you can try the product yourself before talking to sales.7.0 Free trial 14-day trial set up by the vendor, usually after a demo5.0 No free trial Interactive tour and live demo
Contract and lock-inHow we score contract and lock-inMinimum term, whether you can take all your data with you at no extra cost, and other lock-in risks.8.0 Annual Bulk export of documents and metadata; no public terms8.0 Annual Terms defer to the order form; pricing page says annual. Export in PDF, XLSX and CSV; public API
EU data residencyHow we score eu data residencyWhether your data can be hosted in the EU, and how clearly that's documented.8.0 Frankfurt available Also London, Newark, Tokyo; no public DPA10.0 EU (Dublin) Public DPA and subprocessor list
Budget predictabilityHow we score budget predictabilityHow well you can predict future bills: price-increase clauses, price history and the cost of adding users.8.0 No public terms List prices up 17–20% from 2025 to 2026, then moved to tiers5.0 Renewal increases not capped No list prices since 2021; one user reports a hike
Product
Compliance coverageHow we score compliance coverageHow much of ISO 13485, FDA and EU MDR the system covers out of the box, based on its documentation.7.0 ISO 27001; validation pack sold as an add-on; no UDI or vigilance features7.0 No UDI or vigilance reporting features found
Design controls and traceabilityHow we score design controls and traceabilityHow well requirements, risks, tests and software lifecycle are linked, and whether the design history file is generated for you.3.5 Document Holders as phase gates; no documented trace links or IEC 62304 tools9.0 Trace matrix generation; Jira included
UsabilityHow we score usabilityEase-of-use ratings from G2 or Capterra, adjusted for what users repeatedly report.8.0 8.0 9.0 / 10 on G2 663 ratings
Service
Support and onboardingHow we score support and onboardingSupport ratings from review sites, plus whether onboarding help is included in the price.8.0 8.0 9.1 / 10 on G2 561 ratings
Community sentimentHow we score community sentimentOverall review-site rating, adjusted for what independent users say in communities.8.0 4.8/5 on Capterra (11 reviews, all 2015–2022)8.0 4.4/5 on G2 (781 reviews)
Time to go liveHow we score time to go liveHow long it usually takes until your team can work in the system, and whether templates are included.6.0 Weeks to 3 months Vendor estimate; form templates, SOP templates unclear6.0 30–60 days Vendor estimate; 8-week onboarding; templates extra

Scores are out of 10. The better side of each row is highlighted. How we score

Notable features

CognidoxQualio
Built-in document editorNoDocuments are uploaded files edited in their own apps; forms are filled in the browserYesIn-app editor with co-editing; users report weaker formatting than Word
Edit in Word or Google DocsYesOffice add-in for Word, Excel and PowerPoint; cross-platform version needs Office 365Partly or add-onWord via OneDrive integration; Google Docs must be converted
SOP templates includedPartly or add-onCAPA, NCR, change and other form templates included; SOP templates only mentioned vaguelyNoSOP templates are a paid add-on (Content Pathways)
Jira or Git integrationPartly or add-onCommand-line client for source-control hooks and REST/SOAP API; no documented Jira or Git integrationYesJira included; GitHub, GitLab, Azure DevOps via add-on
IEC 62304 software featuresNot confirmed yetNo IEC 62304 features foundNot confirmed yetNo IEC 62304-specific features documented
Validation package includedPartly or add-onValidation pack with IQ/OQ/PQ templates and test evidence, sold as an add-onYesCSA validation pack per release; cost not stated
Public APIPartly or add-onREST and SOAP API; reference docs only inside the product; Scale tier or add-onYesREST API with developer portal, Growth plan only
Single sign-on (SSO)Partly or add-onSAML SSO (Entra ID, Google) on higher packages or as an add-onYesEntra ID, Google and Okta
Supplier portalYesLimited Access Partner accounts give suppliers scoped accessNot confirmed yetNo external supplier portal found
Training with quizzesYesLMS quizzes with question pools and pass marks (Scale tier or LMS add-on)YesMultiple-choice assessments, 100% to pass
FDA MDR or EU vigilance reportingNot confirmed yetNo FDA MDR or EU vigilance reporting feature foundNot confirmed yetNo FDA MDR or EU vigilance reporting found
AI featuresNot confirmed yetNo AI features documented; the new owner plans to add AIYesAI gap analysis; AI Copilot in closed beta
ISO 13485 clause coverage (17 requirements)
ClauseRequirementCognidoxQualio
4.2.4Control of documents
4.2.5Control of records
6.2Training and competence
7.3Design and development
7.3.9Change control
7.4Supplier qualification and control
7.5Production records (DMR/DHR)
UDIUDI management (EU MDR, FDA)
8.2.2Complaint handling
8.2.3Regulatory reporting (FDA MDR, EU vigilance)
MDR 83Post-market surveillance
8.2.4Internal audit
8.3Nonconforming product
8.5.2Corrective action (CAPA)
ISO 14971Risk management file
IEC 62304Software lifecycle
Part 11Electronic signatures
Supported out of the boxPartial, or needs an add-onNot supportedNot confirmed yet

Cognidox or Qualio?

We haven't written a verdict for this pair yet. The comparison above comes from our research on each system; the full reviews explain each score.