Qualityze is an enterprise QMS on Salesforce that is strong on complaints, vigilance reporting, CAPA and supplier quality for manufacturers. The reasons device teams look past it are mostly about design controls and the information it doesn’t publish. Here’s what our evidence shows, which alternatives fit which situation, and when Qualityze remains the better pick.
Why teams look for Qualityze alternatives
Design controls aren’t released yet. Design Control and FMEA are new tools in Release 17.0. In June 2026 that release was still “in progress” and targeted for Q3.1 The current risk module is a general risk register, with no ISO 14971 hazard analysis or risk management file.2 IEC 62304 support is a claim on the medical device page without detail.3
No public prices or terms. Qualityze publishes no prices; the quote depends on modules, users, sites and services.4 The only public figure is $30 per user per month for the lowest licence type on its AppExchange listing, which is a floor, not a price.5 No current subscription terms are published. The only Qualityze terms we could read, a 2016 agreement, renewed automatically and let Qualityze raise prices at renewal with 30 days’ notice and no cap.6 We found no documented way to export all records when you leave, and no public API documentation.7
Hosting and security paperwork. We found no hosting location, data processing agreement or subprocessor list.89 The security page names no certifications.8
Reviews that are hard to read. Qualityze has 4.9/5 from 71 reviews on Capterra (Sep 2026).10 But 23 of its 63 AppExchange reviews were posted in three short windows in late December 2021, 2022 and 2023. At least 40 of the 71 Capterra reviews carry the same reviewer names and titles as AppExchange reviews.510 Capterra reviewers also mention a steep learning curve, a high price and no self-serve trial.10
Little public documentation. There is no public help center or release notes; the support page is a contact form. Features are described mainly in module datasheets, most of them from 2023.1112
Which alternative fits your situation
You need design controls and risk now: Greenlight Guru
Greenlight Guru builds software only for medical device companies.13 Its product tour shows a design control matrix linking user needs, inputs, outputs, verification and validation, next to a risk matrix of hazards, hazardous situations and harms.14 Complaint handling includes a step for deciding whether a regulatory report is needed, which creates a task to prepare the FDA report. We found no eMDR or EUDAMED submission, so Qualityze goes further here.15 eQMS packages start at $12,000 a year, with implementation quoted separately; Vendr reports a median of $43,989 a year.1316 It has no pharma GMP modules, so it suits device-only companies.13
You make devices and drugs and want design controls with EU hosting: Qualio
Qualio runs deviations, OOS and pharmacovigilance in the same platform as its device design controls.17 Design controls support up to three requirement levels with verification and validation test cases and ISO 14971 risk.18 Its subprocessor list names AWS in Dublin as the web-application host, and its DPA lists ISO 27001 certification.1920 Exports cover PDF, Word, XLSX and CSV.21 Qualio doesn’t publish prices either, and every plan carries an implementation fee.22 Complaints are only an example template in the configurable Events module.23
You want to stay on Salesforce, with published prices: Matrix Requirements
Matrix Requirements sells two products. Matrix Quality, formerly Simploud, is a Salesforce-based eQMS with deviations, complaints, nonconformances, suppliers, audits and change control.24 It costs $15, $45, $90 or $125 per user per month by licence type, with a $10,000 minimum annual deal.2425 Its billing page says implementation, migration, validation and training are included.26 Design controls come from Matrix Req, with configurable traceability rules, Jira, GitHub, GitLab and Azure DevOps links and an IEC 62304 template package.272829 The two products run on different platforms, and Matrix Quality’s data region isn’t documented.24 Complaint reportability is only mentioned on a marketing page.30
You make hardware and want public data-protection terms: Arena QMS
Arena QMS ties CAPAs, complaints and training to the same parts and change orders that engineering uses.31 Suppliers get their own licences and role-based access to the product record.32 Arena runs a European instance on AWS, and PTC publishes a data processing addendum and a sub-processor list.333435 It has a public REST API, and you can request a 10-day free trial without a credit card.363738 Pricing is quote-only, and the validation package costs extra.37 We found no risk register, and no eMDR or EUDAMED submission.3940
When to stay with Qualityze
Qualityze is a sound choice if these strengths matter more to you than the gaps above:
- Complaints and vigilance. Each region can have its own reportability decision tree, and pre-configured FDA MedWatch 3500 and EU MEDDEV 2.12-1 forms are included.41 The adverse event module claims eMDR XML submissions, and a device customer reports setting up eMDR submission for go-live.425
- Manufacturing workflows. CAPA, nonconformance with material review board disposition, field safety actions and a supplier portal for SCARs are documented step by step.43444546
- Services in the quote. The vendor says guided implementation is part of every quote and a validation package comes with every update at no extra fee.4
- Salesforce. It passed Salesforce’s security review in October 2024, with SSO and multi-factor authentication through Salesforce.58
- Scale. ZimVie runs it with 750 licences.47
If design controls are the only gap, ask Qualityze to demonstrate the shipped Release 17.0 module before you sign.1
Qualityze Insider newsletter, June 2026 (PDF). Vendor newsletter, Jun 2026. ↩︎ ↩︎
Qualityze: Risk management datasheet (PDF). Vendor documentation, updated May 2026. ↩︎
Qualityze: Quality management software for medical devices. Vendor website, checked 30 Sep 2026. ↩︎
Qualityze: Pricing. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎
Salesforce AppExchange: Qualityze listing and reviews. Marketplace listing (vendor-supplied pricing) and 63 user reviews, read 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎
Qualityze Master Subscription Agreement (last updated 9 Mar 2016), on its AppExchange listing (Wayback Machine capture). Vendor terms, archived 17 Jan 2021, checked 1 Oct 2026. ↩︎
Qualityze: Homepage. Vendor website, checked 30 Sep 2026. ↩︎
Qualityze: Security. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎
Qualityze: Privacy policy. Vendor legal page, checked 30 Sep 2026. ↩︎
Capterra: Qualityze Suite reviews. Review site, ratings checked in a browser 30 Sep 2026; review texts read 30 Sep 2026. ↩︎ ↩︎ ↩︎
Qualityze: Support. Vendor website, checked 30 Sep 2026. ↩︎
Qualityze: Downloads (datasheets, brochures, case studies). Vendor website, checked 30 Sep 2026. ↩︎
Greenlight Guru: Quality pricing and packages. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎ ↩︎
Greenlight Guru: Interactive product tour. Vendor product tour with screenshots (captured 2024), checked 30 Sep 2026. ↩︎
Greenlight Guru: Complaint management software. Vendor website, checked 29 Sep 2026. ↩︎
Vendr: Greenlight Guru pricing. Price benchmark, checked 29 Sep 2026. ↩︎
Qualio: Pharma quality management software. Vendor website, checked 29 Sep 2026. ↩︎
Getting Started with Design Controls in Qualio. Vendor help center, checked 29 Sep 2026. ↩︎
Terms and Policies (subprocessor list). Vendor help center, 24 Nov 2025. ↩︎
Qualio: Data Processing Addendum. Vendor legal page, checked 29 Sep 2026. ↩︎
User Permissions. Vendor help center, checked 29 Sep 2026. ↩︎
Qualio: Plans and pricing. Vendor website, checked 29 Sep 2026. ↩︎
Forms and Qualio. Vendor help center, checked 29 Sep 2026. ↩︎
Matrix One: Matrix Quality product page, ROI calculator and FAQ. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎ ↩︎
Simploud: Cost calculator. Vendor website, checked 29 Sep 2026. ↩︎
Simploud Academy: Billing. Help center, checked 29 Sep 2026. ↩︎
Matrix One user manual: Traceability. Help center, checked 29 Sep 2026. ↩︎
Matrix One user manual: GitHub and GitLab integration. Help center, checked 29 Sep 2026. ↩︎
Matrix One blog: SxMD templates package. Vendor blog, published 2 Oct 2023. ↩︎
Matrix One: Quality events and CAPA in Matrix Quality. Vendor marketing page, checked 29 Sep 2026. ↩︎
Arena: Quality management solution brief. Vendor website, checked 4 Oct 2026. ↩︎
Arena: Supply chain collaboration. Vendor website, checked 4 Oct 2026. ↩︎
Arena: Security platform. Vendor website, checked 4 Oct 2026. ↩︎
PTC: Cybersecurity and data privacy addendum. Vendor legal page (DPAv2, Jan 2023), checked 4 Oct 2026. ↩︎
PTC: Sub-processors list. Vendor legal page, effective Mar 2024. ↩︎
Arena REST API (Swagger UI). Vendor documentation, checked 4 Oct 2026. ↩︎
Arena: Plans and pricing. Vendor website, checked 4 Oct 2026. ↩︎ ↩︎
Arena: Request a free trial. Vendor website, checked 4 Oct 2026. ↩︎
AWS Marketplace: Arena PLM + QMS reviews (447 G2 reviews). Review site (syndicated from G2), checked 4 Oct 2026. ↩︎
Arena: EU MDR guide, how Arena can help. Vendor white paper, checked 4 Oct 2026. ↩︎
Qualityze: Complaint management datasheet (PDF). Vendor documentation, 2023. ↩︎
Qualityze: Adverse event management. Vendor website, checked 30 Sep 2026. ↩︎
Qualityze: CAPA management datasheet (PDF). Vendor documentation, updated May 2026. ↩︎
Qualityze: Nonconformance management datasheet (PDF). Vendor documentation, 2023. ↩︎
Qualityze: Field safety and recall management datasheet (PDF). Vendor documentation, 2024. ↩︎
Qualityze: Supplier management datasheet (PDF). Vendor documentation, 2023. ↩︎
Qualityze: ZimVie case study (PDF). Vendor case study, 2024. ↩︎
Why people switch: Design controls and FMEA are still unreleased roadmap items, there are no public prices, terms, DPA or hosting details, and many reviews were posted in year-end bursts. Read our Qualityze review.
- 1
OpenRegulatory Formwork
OpenRegulatory (OpenReg GmbH), $7k/yr
You're an early-stage device startup, especially one building software, and want a cheap, self-serve QMS with templates and linked requirements, risks and tests.Watch out: Complaints are logged as incidents with no documented investigation step, and we found no internal audit planning, UDI or DMR/DHR features. The vendor has no ISO 27001 certification and offers no audit rights.
7.8out of 10 - 2
Matrix Requirements (Matrix One)
Matrix One (Matrix Requirements GmbH), from $22k/yr
You build software or software-heavy devices and need design controls, risk and test traceability tied to your QMS.Watch out: A full QMS takes two products from Matrix One: Matrix Req, plus Matrix Quality, a Salesforce-based eQMS acquired in 2026 and priced separately.
7.5out of 10 - 3
Greenlight Guru
Greenlight Guru, from $12k/yr
You build a medical device, want design controls, ISO 14971 risk and quality events linked in one MedTech-only system, and can budget well above the entry price.Watch out: Users report the bill growing quickly as the team grows, and implementation is charged on top of the subscription.
7.4out of 10 - 4
Cognidox
Cognidox Ltd (part of Recur Software), from $8k/yr
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. The validation pack and SSO are unpriced add-ons, and the LMS needs the Scale tier or an add-on.
7.2out of 10 - 5
SimplerQMS
SimplerQMS A/S, from $17.5k/yr
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.
7.1out of 10 - 6
Qualio
Qualio, Inc., est. $12–30k/yr
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.
6.8out of 10 - 7
Orcanos
Orcanos Ltd., pricing on request
You build a software-heavy or electromechanical device and want requirements, risk, tests and QMS records traced in one system rather than two tools joined by an integration.Watch out: Prices are not published, and supplier, audit, nonconformance and complaint workflows are described mainly on marketing pages rather than in the help center.
6.7out of 10 - 8
Arena QMS
Arena, a PTC business, est. $12–25k/yr
You build physical medical devices with outsourced manufacturing and want CAPA, complaints, training and design records linked to the same BOM and change orders as your engineering data.Watch out: Pricing is quote-only with paid implementation and validation add-ons. There is no risk register, IEC 62304 support or electronic regulatory reporting.
6.6out of 10 - 9
Ketryx
Ketryx Corporation, pricing on request
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.
6.5out of 10 - 10
Ideagen Quality Management
Ideagen, est. $22–29k/yr
You make physical devices or combination products, want proven CAPA, audit, supplier and document workflows with Part 11 signatures, and handle design controls and risk files elsewhere.Watch out: Design controls, ISO 14971 risk files, vigilance reporting and IEC 62304 support aren't documented as product features, and the standard agreement defaults to 24 months with automatic renewal unless the order form says otherwise.
6.4out of 10 - 11
Scilife
Scilife NV, pricing on request
You run a GMP-regulated pharma, biotech or combined device and pharma operation and want an easy-to-learn eQMS with validation documents included.Watch out: Device-specific features are thin: risk isn't linked to design controls, complaints use a generic events workflow, and there's no Jira or Git integration.
6.3out of 10 - 12
Dot Compliance
Dot Compliance Ltd., pricing on request
You run a device, pharma or combination-product company and want a pre-configured GxP quality system on Salesforce that goes live in weeks to a few months.Watch out: Prices, contract terms and data export aren't published, and there's no documented support for software development (IEC 62304) or developer tools.
5.9out of 10 - 13
ETQ Reliance (Octave Reliance)
Octave Intelligence plc (formerly ETQ), pricing on request
You run a multi-site medical device or combined device and pharma manufacturer and want one configurable system for documents, CAPA, complaints with eMDR, suppliers and audits across sites.Watch out: There's no design-controls, ISO 14971 risk-file or IEC 62304 module, and prices, contract length and hosting regions aren't published.
5.1out of 10 - 14
MasterControl
MasterControl Solutions, Inc., est. $25–72k/yr
You run a larger, multi-site device or combined device-and-pharma quality organisation and need a configurable, validated system for documents, training, CAPA and audits.Watch out: Prices, hosting location and exit terms aren't published, and design controls, risk files and software development support are weak for device R&D teams.
5.1out of 10
Qualityze vs the top alternatives
| Qualityze | OpenRegulatory Formwork | Matrix Requirements (Matrix One) | Greenlight Guru | Cognidox | |
|---|---|---|---|---|---|
| Built-in document editor | Not confirmed yetDocuments are checked in or authored in Microsoft 365 or Google; no built-in editor found | YesRich-text editor with tables and images, stored as Markdown | YesRich-text editor for items and generated documents | NoDocuments are files; 2024 tour shows upload and download, editing via Office or Google | NoDocuments are uploaded files edited in their own apps; forms are filled in the browser |
| Edit in Word or Google Docs | Partly or add-onSharePoint and Google Drive integration; two-way sync announced for Service Pack 16.10 | Partly or add-onGoogle Docs and Sheets edited in Google with sync; Word files can be uploaded but not edited in place | Partly or add-onMatrix Quality only (Office 365, SharePoint/Google); Matrix Req imports Word but can't edit in it | YesCo-edit in Google Docs and Microsoft Office for the web | YesOffice add-in for Word, Excel and PowerPoint; cross-platform version needs Office 365 |
| SOP templates included | Not confirmed yetWorkflow and validation templates; no SOP template package found | YesOpenRegulatory's free QMS and technical documentation templates built in | YesSxMD SOP and document templates on Company plans | YesQMS templates listed in the eQMS package; 70+ SOPs and forms | Partly or add-onCAPA, NCR, change and other form templates included; SOP templates only mentioned vaguely |
| Jira or Git integration | Not confirmed yetNo Jira or Git integration found | NoVendor says there's no Jira or development-tool integration, by design; CI pipelines can file test results through the MCP API | YesJira, GitHub, GitLab and Azure DevOps | YesJira and GitHub integrations | Partly or add-onCommand-line client for source-control hooks and REST/SOAP API; no documented Jira or Git integration |
| IEC 62304 software features | Not confirmed yetOnly a marketing claim | YesSafety class per product, requirement categories, detailed design for class C, tests and test runs | YesSoftware traceability and IEC 62304 templates | YesSoftware release management aligned to IEC 62304; SBOM scanning | Not confirmed yetNo IEC 62304 features found |
| Validation package included | YesValidation plan, test scripts, IQ/PQ, trace matrix and report with every update | YesPre-filled validation report with screenshots of each tested requirement, generated in the app | YesValidation project with plans, tests and reports | YesIQ protocol plus OQ/PQ reports with every release, included | Partly or add-onValidation pack with IQ/OQ/PQ templates and test evidence, sold as an add-on |
| Public API | Partly or add-on'API-first' claim and integration services; no public API documentation | Partly or add-onMCP (JSON-RPC) API with API tokens and a public tools reference; no REST API | YesDocumented REST API; Salesforce APIs for Matrix Quality | Partly or add-onREST API exists; documentation is for customers only | Partly or add-onREST and SOAP API; reference docs only inside the product; Scale tier or add-on |
| Single sign-on (SSO) | YesSSO and MFA through Salesforce | Partly or add-onGoogle sign-in; no SAML SSO found | YesMatrix Req: Enterprise Plus only; Matrix Quality via Salesforce | YesSSO listed as a platform feature | Partly or add-onSAML SSO (Entra ID, Google) on higher packages or as an add-on |
| Supplier portal | YesSupplier portal for SCARs, audit responses and communication | Not confirmed yetSupplier list for your own evaluations; no supplier access found | YesMatrix Quality portal for supplier forms and SCARs | Partly or add-onSecure sharing with suppliers; no dedicated portal documented | YesLimited Access Partner accounts give suppliers scoped access |
| Training with quizzes | YesExams with automatic grading; AI-generated quizzes | YesTraining effectiveness by quiz or a named person (paid plans) | YesMultiple-choice training questions in Matrix Req | YesAI drafts training quizzes | YesLMS quizzes with question pools and pass marks (Scale tier or LMS add-on) |
| FDA MDR or EU vigilance reporting | YesMedWatch and MEDDEV forms, reportability decision tree, eMDR XML export | Partly or add-onIncidents record whether they are serious and reportable; no MDR or EU vigilance report forms | Partly or add-onReportability assessment on a marketing page only | Partly or add-onReportability decision and report task; no eMDR submission | Not confirmed yetNo FDA MDR or EU vigilance reporting feature found |
| AI features | YesAI agents in nonconformance, audit, document and training modules | YesAI drafting of QMS and technical documents; data goes to OpenAI only when you click generate | YesMatrix Mind, AI design tools, compliance checker | YesGreenlight Guru AI: search, answers, summaries; ISO 42001 | Not confirmed yetNo AI features documented; the new owner plans to add AI |