CompareQualio vs SimplerQMS
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.
from $17.5k/yr
Minimum $17,500 a year covers up to 15 users
Choose it if: You run a small or mid-sized device or pharma company, write your SOPs in Microsoft Word, and want implementation, validation and training included in one yearly price.
Watch out: Design controls, risk and software lifecycle are managed as documents with no native traceability, and contracts auto-renew with a 90-day notice period and a 5% yearly price rise.
| Qualio 6.8 | SimplerQMS 7.1 | |
|---|---|---|
| Price and buying | ||
| AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees. | 5.5 est. $12–30k/yr Estimate from 2019–2021 list prices; implementation fee extra | 7.0 from $17.5k/yr Minimum $17,500 a year covers up to 15 users |
| Price transparencyHow we score price transparencyWhether the vendor publishes its prices on its own website. | 2.0 No public prices Published until 2021; implementation fee not published | 6.0 Starting price only Services included; licence prices not published |
| Try before you buyHow we score try before you buyWhether you can try the product yourself before talking to sales. | 5.0 No free trial Interactive tour and live demo | 7.0 Free trial Guided trial after a call; interactive tours |
| 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 Terms defer to the order form; pricing page says annual. Export in PDF, XLSX and CSV; public API | 8.0 Annual Auto-renews, 90-day notice; export to Excel/CSV plus files |
| EU data residencyHow we score eu data residencyWhether your data can be hosted in the EU, and how clearly that's documented. | 10.0 EU (Dublin) Public DPA and subprocessor list | 8.0 EU or US, selectable Public DPA; no current 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 Renewal increases not capped No list prices since 2021; one user reports a hike | 7.0 Fixed 5% increase every January Starter entry price up 27% since 2024 (now covers 15 users) |
| 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 No UDI or vigilance reporting features found | 8.0 Validation package and ISO 27001; no UDI or eMDR 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. | 9.0 Trace matrix generation; Jira included | 3.5 Design, risk and software files are documents; no trace links |
| UsabilityHow we score usabilityEase-of-use ratings from G2 or Capterra, adjusted for what users repeatedly report. | 8.0 9.0 / 10 on G2 663 ratings | 8.0 8.3 / 10 on G2 13 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 9.1 / 10 on G2 561 ratings | 8.0 9.4 / 10 on G2 13 ratings |
| Community sentimentHow we score community sentimentOverall review-site rating, adjusted for what independent users say in communities. | 8.0 4.4/5 on G2 (781 reviews) | 8.0 4.5/5 on Capterra (36 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 30–60 days Vendor estimate; 8-week onboarding; templates extra | 7.0 5–8 weeks Vendor estimate; ISO 13485 templates included |
Scores are out of 10. The better side of each row is highlighted. How we score
| Qualio | SimplerQMS | |
|---|---|---|
| Built-in document editor | YesIn-app editor with co-editing; users report weaker formatting than Word | NoDocuments are written in Microsoft Office, not in a built-in editor |
| Edit in Word or Google Docs | Partly or add-onWord via OneDrive integration; Google Docs must be converted | YesWord, Excel and PowerPoint via Microsoft 365 and a Word add-in; Microsoft 365 licences required |
| SOP templates included | NoSOP templates are a paid add-on (Content Pathways) | YesISO 13485 and 21 CFR 820 template packages included |
| Jira or Git integration | YesJira included; GitHub, GitLab, Azure DevOps via add-on | Partly or add-onJira named on marketing pages; no documented integration |
| IEC 62304 software features | Not confirmed yetNo IEC 62304-specific features documented | Not confirmed yetOnly a generic 'supports alignment with IEC 62304' claim |
| Validation package included | YesCSA validation pack per release; cost not stated | YesValidation plan, report and IQ/OQ/PQ included; revalidated each release |
| Public API | YesREST API with developer portal, Growth plan only | Partly or add-onAPI stated and API keys in admin settings; no public documentation |
| Single sign-on (SSO) | YesEntra ID, Google and Okta | YesMicrosoft Entra ID and Google Workspace on all licence types |
| Supplier portal | Not confirmed yetNo external supplier portal found | Not confirmed yetNo supplier portal found |
| Training with quizzes | YesMultiple-choice assessments, 100% to pass | YesMultiple-choice quizzes with a quiz report |
| FDA MDR or EU vigilance reporting | Not confirmed yetNo FDA MDR or EU vigilance reporting found | Partly or add-onVigilance reportability assessment; reports filed outside the system |
| AI features | YesAI gap analysis; AI Copilot in closed beta | YesAI-generated change summaries when sending documents for approval |
| Clause | Requirement | Qualio | SimplerQMS |
|---|---|---|---|
| 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.