on request
No public or reported prices for paid plans
Choose it if: You build software as a medical device, your engineers live in Jira and Git, and you want design controls, risk and IEC 62304 records generated from that work.
Watch out: We found no documented supplier, internal audit, DMR/DHR or vigilance-reporting workflows, so most device companies will run it next to another eQMS.
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.
| Ketryx 6.5 | Qualio 6.8 | |
|---|---|---|
| Price and buying | ||
| AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees. | 4.0 on request No public or reported prices for paid plans | 5.5 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 Free plan only Paid plans are contact-sales | 2.0 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. | 10.0 Free trial Self-serve 30 days, no credit card | 5.0 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 JSON, PDF and CSV exports; API | 8.0 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. | 7.0 EU available AWS US or EU; plan terms not stated; public DPA | 10.0 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. | 5.0 No cap on renewal increases No paid list prices ever published; no renewal-hike reports found | 5.0 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. | 6.5 ISO 27001, SOC 2 Type 2; no supplier or audit workflow found | 7.0 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. | 10.0 Generated DHF, trace matrix and risk file from Jira and Git | 9.0 Trace matrix generation; Jira included |
| UsabilityHow we score usabilityEase-of-use ratings from G2 or Capterra, adjusted for what users repeatedly report. | 5.0 No usable rating 2 reviews on G2 | 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. | 5.0 No usable rating 2 reviews on G2 | 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. | 5.0 4.8/5 on G2 from 2 reviews; too few to score | 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 10 weeks–3 months Case studies and a user report | 6.0 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
| Ketryx | Qualio | |
|---|---|---|
| Built-in document editor | YesBuilt-in text editor for EDMS documents | YesIn-app editor with co-editing; users report weaker formatting than Word |
| Edit in Word or Google Docs | Partly or add-onGoogle Drive sync; SharePoint publishing in limited rollout; no in-browser Word editing | Partly or add-onWord via OneDrive integration; Google Docs must be converted |
| SOP templates included | Partly or add-on20 SOP templates; listed on higher plans in 2024–2025 | NoSOP templates are a paid add-on (Content Pathways) |
| Jira or Git integration | YesJira, GitHub, GitLab, Bitbucket, Azure DevOps | YesJira included; GitHub, GitLab, Azure DevOps via add-on |
| IEC 62304 software features | YesIEC 62304-certified platform, SOUP/SBOM, anomalies, release gates | Not confirmed yetNo IEC 62304-specific features documented |
| Validation package included | YesValidation package with every major and minor release | YesCSA validation pack per release; cost not stated |
| Public API | YesBuild, Project, Item and Group APIs, webhooks | YesREST API with developer portal, Growth plan only |
| Single sign-on (SSO) | YesGoogle, GitHub, Okta or any OpenID Connect provider | YesEntra ID, Google and Okta |
| Supplier portal | Not confirmed yetNo evidence found | Not confirmed yetNo external supplier portal found |
| Training with quizzes | Not confirmed yetRead-and-acknowledge training documented; no quizzes found | YesMultiple-choice assessments, 100% to pass |
| FDA MDR or EU vigilance reporting | Not confirmed yetAdverse-event complaint types, but no documented MDR or vigilance reports | Not confirmed yetNo FDA MDR or EU vigilance reporting found |
| AI features | YesAI agents for CAPA drafts, complaint trends and quality review | YesAI gap analysis; AI Copilot in closed beta |
| Clause | Requirement | Ketryx | Qualio |
|---|---|---|---|
| 4.2.4 | Control of documents | ||
| 4.2.5 | Control of records | ||
| 6.2 | Training and competence | ||
| 7.3 | Design and development | ||
| 7.3.9 | Change control | ||
| 7.4 | Supplier qualification and control | ||
| 7.5 | Production records (DMR/DHR) | ||
| UDI | UDI management (EU MDR, FDA) | ||
| 8.2.2 | Complaint handling | ||
| 8.2.3 | Regulatory reporting (FDA MDR, EU vigilance) | ||
| MDR 83 | Post-market surveillance | ||
| 8.2.4 | Internal audit | ||
| 8.3 | Nonconforming product | ||
| 8.5.2 | Corrective action (CAPA) | ||
| ISO 14971 | Risk management file | ||
| IEC 62304 | Software lifecycle | ||
| Part 11 | Electronic signatures |
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.