Ketryx alternatives for medical device companies

The best alternatives to Ketryx, ranked by overall score.

By · Updated

Ketryx is built for software device teams whose engineers work in Jira and Git. The reasons people look at other tools usually come from what Ketryx leaves out: it isn’t a complete device QMS, and its prices are hidden. Here’s what our evidence shows, which alternatives fit which situation, and when Ketryx remains the better pick.

Why teams look for Ketryx alternatives

It doesn’t cover the whole QMS. We found no documented workflow for supplier control, internal audits, production records (DMR/DHR), UDI or vigilance reporting.1 Its templated QMS includes SOPs for internal audit and purchasing, but those are documents, not system features.2 Ketryx itself describes the platform as a bridge between engineering tools and your existing eQMS.3 The complaint workflow has no documented reportability step, and the documented nonconformance workflow covers software anomalies only.45

No prices. The Free plan costs $0 but is limited to pre-market companies that raised less than $2 million. Startup, Business and Enterprise are “contact sales”.6 We found no price paid in reviews, forums or benchmark sites. The terms let Ketryx raise fees at renewal, with no cap.7

Hosting per plan is unclear. The subprocessor list names AWS in the US and the EU, but doesn’t say whether EU hosting is available on every plan.8

Little independent feedback. Ketryx has 2 reviews on G2 and no Capterra listing.9 First-hand reports on Reddit are few and mixed. One user reports a lot to learn, another says the Jira integration was tricky to set up, and a user moving from a traditional eQMS finds Ketryx short on flexibility and controls.101112

Which alternative fits your situation

You want one eQMS that also handles software releases: Greenlight Guru

Greenlight Guru covers document control, change control, training, suppliers, audits, CAPA, complaints and nonconformances, next to requirements, design controls and ISO 14971 risk.13 For software it offers IEC 62304-aligned release management, Jira and GitHub sync, and SBOM scanning.1415 Complaint handling includes a step for deciding whether a regulatory report is needed.16 It publishes an entry price of $12,000 a year, with implementation quoted separately, but Vendr reports a median of $43,989 a year.1317 We found no free trial.18

You want traceability plus supplier and audit workflows: Matrix Requirements

Matrix Requirements documents configurable traceability rules and issue links to Jira, GitHub, GitLab and Azure DevOps.1920 Its SxMD template package covers IEC 62304 on Company and Enterprise plans.21 Supplier and audit workflows come from a second product, Matrix Quality, which runs on Salesforce.2223 Both products publish prices: Matrix Req Team Plus plus ten Matrix Quality licences comes to about $21.8k a year (September 2026).2425 You can start a Matrix Req trial yourself.26 Matrix Quality’s hosting region isn’t documented.25

You want engineering and quality in one database: Orcanos

In Orcanos, requirements, risk, tests, CAPAs and quality records share one database, so there’s no integration to maintain.27 Software teams get IEC 62304 compliance checks that take a software safety class, and test automation through the API.2829 Hardware teams get engineering change orders and electronic device history records.3031 The trade-offs: Jira connects only through Zapier, prices aren’t published, and we found no free trial.323327 Supplier and audit features appear only on marketing pages.3435

You’re an early-stage startup and price matters most: Formwork

Formwork publishes flat prices: 499 € a month plus VAT for unlimited users, and a free tier you can sign up for yourself.3637 Each product records its IEC 62304 safety class, and requirements link to risk controls and tests.3839 Supplier re-evaluation follows each supplier’s criticality.40 It has gaps a Ketryx user will notice. There’s no Jira or Git integration, by design.41 Complaints are logged as incidents with no documented investigation step, and we found no internal audit planning.4243 The vendor has no ISO 27001 certification, and Formwork has 2 reviews on G2, too few for a rating.4445

When to stay with Ketryx

Ketryx does its core job well, and many teams run it next to another eQMS on purpose:

  • Records generated from engineering work. Requirements, software items, tests and risks sync from Jira, Git and test tools, and Ketryx generates the design history file from them.46 Release gates can block a release until traceability is complete.47
  • Certified platform. The platform itself is certified to IEC 62304, ISO 13485 and ISO 14971 by UL Solutions.48 A validation package comes with every major and minor release.49
  • SOUP tracking. It tracks SOUP through a software bill of materials and emails users about new vulnerabilities in released versions.47
  • Easy to try and to leave. You can start a 30-day trial without a credit card, and a full project exports as a JSON archive.5051
  • Security. Ketryx holds ISO/IEC 27001:2022 and SOC 2 Type 2.48

  1. Ketryx: AI-readable site index. Vendor website mirror (743 pages searched), checked 30 Sep 2026. ↩︎

  2. Ketryx help center: How can I use Ketryx for ISO 13485 compliance? Help center, checked 30 Sep 2026. ↩︎

  3. Ketryx: Medical devices. Vendor website, checked 30 Sep 2026. ↩︎

  4. Ketryx docs: WI-07 Complaint (archived). Product documentation, captured 22 Apr 2024. ↩︎

  5. Ketryx docs: WI-06 Anomaly (archived). Product documentation, captured 22 Apr 2024. ↩︎

  6. Ketryx: Pricing. Vendor website, checked 4 Oct 2026. ↩︎

  7. Ketryx: Terms of Service. Vendor terms, checked 1 Oct 2026. ↩︎

  8. Ketryx Trust Center. Vendor trust center, checked in a browser 30 Sep 2026. ↩︎

  9. G2: Ketryx Connected Lifecycle Management reviews. Review site, checked in a browser 30 Sep 2026. ↩︎

  10. Reddit r/MedicalDevices: comment by a Ketryx user. Community post, Mar 2025. ↩︎

  11. Reddit r/ProductManagement: comment by a Ketryx user. Community post, Jul 2025. ↩︎

  12. Reddit r/MedicalDevices: Ketryx for eQMS. Community post, Sep 2026. ↩︎

  13. Greenlight Guru: Quality pricing and packages. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎

  14. Greenlight Guru: Ultralight eQMS. Vendor website, checked 29 Sep 2026. ↩︎

  15. Greenlight Guru: Product development for SiMD/SaMD. Vendor website, checked 29 Sep 2026. ↩︎

  16. Greenlight Guru: Complaint management software. Vendor website, checked 29 Sep 2026. ↩︎

  17. Vendr: Greenlight Guru pricing. Price benchmark, checked 29 Sep 2026. ↩︎

  18. Greenlight Guru: Quality management software product tour. Vendor website, checked 29 Sep 2026. ↩︎

  19. Matrix One user manual: Traceability. Help center, checked 29 Sep 2026. ↩︎

  20. Matrix One user manual: GitHub and GitLab integration. Help center, checked 29 Sep 2026. ↩︎

  21. Matrix One blog: SxMD templates package. Vendor blog, published 2 Oct 2023. ↩︎

  22. Simploud Academy: Suppliers with portal (session recording). Help center video, checked 29 Sep 2026. ↩︎

  23. Simploud Academy: Audit management (webinar). Help center video, published 9 Dec 2025. ↩︎

  24. Matrix One: Company Plus plan page. Unlinked vendor price page, updated Feb 2026, checked 29 Sep 2026. ↩︎

  25. Matrix One: Matrix Quality product page, ROI calculator and FAQ. Vendor website, checked 29 Sep 2026. ↩︎ ↩︎

  26. Matrix One: Free trial. Vendor website, checked 29 Sep 2026. ↩︎

  27. Orcanos: homepage. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  28. Orcanos help center: Audit Insights (compliance and governance). Help center, checked 30 Sep 2026. ↩︎

  29. Orcanos help center: How to automate tests. Help center, checked 30 Sep 2026. ↩︎

  30. Orcanos help center: ECO. Help center, updated 1 Feb 2026. ↩︎

  31. Orcanos help center: Adding a new e-DHR item. Help center, checked 30 Sep 2026. ↩︎

  32. Orcanos help center: Jira integration through Zapier. Help center, updated 13 Apr 2026. ↩︎

  33. Orcanos: Pricing. Vendor website, checked 4 Oct 2026. ↩︎

  34. Orcanos: Supplier qualification management. Vendor marketing page, checked 30 Sep 2026. ↩︎

  35. Orcanos: Audit management. Vendor marketing page, checked 30 Sep 2026. ↩︎

  36. Formwork pricing, archived 3 Oct 2026. Vendor website (Wayback Machine), read 4 Oct 2026; also checked in a browser 1 Oct 2026. ↩︎

  37. Formwork sign-up page. Vendor website, checked 4 Oct 2026. ↩︎

  38. Documenting your medical device in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎

  39. Software requirements and design inputs in Formwork, archived 25 Apr 2025. Vendor documentation, updated 1 Oct 2024. ↩︎

  40. Formwork Manual: Suppliers. Vendor documentation, checked 1 Oct 2026. ↩︎

  41. Formwork product page and FAQ, archived 19 Feb 2026. Vendor website (Wayback Machine), checked 4 Oct 2026. ↩︎

  42. Formwork Manual: Incidents & Complaints, archived 4 Oct 2026. Vendor documentation, published 9 Sep 2026. ↩︎

  43. Formwork Manual: Non Conformities, archived 4 Oct 2026. Vendor documentation, published 9 Sep 2026. ↩︎

  44. Formwork Manual: Compliance & Passing Audits, archived 4 Oct 2026. Vendor documentation, published 22 Jan 2026. ↩︎

  45. G2: Formwork eQMS reviews. Review site, checked 30 Sep 2026. ↩︎

  46. Ketryx docs: How to generate the Design History File for your medical device (archived). Product documentation, captured 15 Oct 2025. ↩︎

  47. Ketryx: Ketryx 2.11 release. Release notes, published 27 Jan 2025. ↩︎ ↩︎

  48. Ketryx: Certifications. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎

  49. Ketryx: Inside Ketryx’s customer validation package. Vendor blog, published 12 Dec 2025. ↩︎

  50. Ketryx: Sign up for a free trial. Vendor website, checked 30 Sep 2026. ↩︎

  51. Ketryx docs: MAN-13 Data Export (archived). Product documentation, captured 28 Apr 2025. ↩︎

Why people switch: We found no documented supplier, internal audit, DMR/DHR or vigilance-reporting workflows, so most device companies will run it next to another eQMS. Read our Ketryx review.

  1. 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
    Read the OpenRegulatory Formwork review OpenRegulatory Formwork alternatives
  2. 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
    Read the Matrix Requirements (Matrix One) review Matrix Requirements alternatives
  3. 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
    Read the Greenlight Guru review Greenlight Guru alternatives
  4. 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
    Read the Cognidox review Cognidox alternatives
  5. 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
    Read the SimplerQMS review SimplerQMS alternatives
  6. 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
    Read the Qualio review Qualio alternatives
  7. 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
    Read the Orcanos review Orcanos alternatives
  8. 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
    Read the Arena QMS review Arena QMS alternatives
  9. 9

    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
    Read the Ideagen Quality Management review Ideagen Quality Management alternatives
  10. 10

    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
    Read the Scilife review Scilife alternatives
  11. 11

    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
    Read the Dot Compliance review Dot Compliance alternatives
  12. 12

    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
    Read the ETQ Reliance (Octave Reliance) review ETQ Reliance alternatives
  13. 13

    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
    Read the MasterControl review MasterControl alternatives
  14. 14

    Qualityze

    Qualityze Inc., pricing on request

    You make physical devices or combine devices and pharma, already use Salesforce or want to, and need configurable complaint, vigilance, CAPA and supplier workflows across several sites.Watch out: 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.

    5.1out of 10
    Read the Qualityze review Qualityze alternatives

Ketryx vs the top alternatives

KetryxOpenRegulatory FormworkMatrix Requirements (Matrix One)Greenlight GuruCognidox
Built-in document editorYesBuilt-in text editor for EDMS documentsYesRich-text editor with tables and images, stored as MarkdownYesRich-text editor for items and generated documentsNoDocuments are files; 2024 tour shows upload and download, editing via Office or GoogleNoDocuments are uploaded files edited in their own apps; forms are filled in the browser
Edit in Word or Google DocsPartly or add-onGoogle Drive sync; SharePoint publishing in limited rollout; no in-browser Word editingPartly or add-onGoogle Docs and Sheets edited in Google with sync; Word files can be uploaded but not edited in placePartly or add-onMatrix Quality only (Office 365, SharePoint/Google); Matrix Req imports Word but can't edit in itYesCo-edit in Google Docs and Microsoft Office for the webYesOffice add-in for Word, Excel and PowerPoint; cross-platform version needs Office 365
SOP templates includedPartly or add-on20 SOP templates; listed on higher plans in 2024–2025YesOpenRegulatory's free QMS and technical documentation templates built inYesSxMD SOP and document templates on Company plansYesQMS templates listed in the eQMS package; 70+ SOPs and formsPartly or add-onCAPA, NCR, change and other form templates included; SOP templates only mentioned vaguely
Jira or Git integrationYesJira, GitHub, GitLab, Bitbucket, Azure DevOpsNoVendor says there's no Jira or development-tool integration, by design; CI pipelines can file test results through the MCP APIYesJira, GitHub, GitLab and Azure DevOpsYesJira and GitHub integrationsPartly or add-onCommand-line client for source-control hooks and REST/SOAP API; no documented Jira or Git integration
IEC 62304 software featuresYesIEC 62304-certified platform, SOUP/SBOM, anomalies, release gatesYesSafety class per product, requirement categories, detailed design for class C, tests and test runsYesSoftware traceability and IEC 62304 templatesYesSoftware release management aligned to IEC 62304; SBOM scanningNot confirmed yetNo IEC 62304 features found
Validation package includedYesValidation package with every major and minor releaseYesPre-filled validation report with screenshots of each tested requirement, generated in the appYesValidation project with plans, tests and reportsYesIQ protocol plus OQ/PQ reports with every release, includedPartly or add-onValidation pack with IQ/OQ/PQ templates and test evidence, sold as an add-on
Public APIYesBuild, Project, Item and Group APIs, webhooksPartly or add-onMCP (JSON-RPC) API with API tokens and a public tools reference; no REST APIYesDocumented REST API; Salesforce APIs for Matrix QualityPartly or add-onREST API exists; documentation is for customers onlyPartly or add-onREST and SOAP API; reference docs only inside the product; Scale tier or add-on
Single sign-on (SSO)YesGoogle, GitHub, Okta or any OpenID Connect providerPartly or add-onGoogle sign-in; no SAML SSO foundYesMatrix Req: Enterprise Plus only; Matrix Quality via SalesforceYesSSO listed as a platform featurePartly or add-onSAML SSO (Entra ID, Google) on higher packages or as an add-on
Supplier portalNot confirmed yetNo evidence foundNot confirmed yetSupplier list for your own evaluations; no supplier access foundYesMatrix Quality portal for supplier forms and SCARsPartly or add-onSecure sharing with suppliers; no dedicated portal documentedYesLimited Access Partner accounts give suppliers scoped access
Training with quizzesNot confirmed yetRead-and-acknowledge training documented; no quizzes foundYesTraining effectiveness by quiz or a named person (paid plans)YesMultiple-choice training questions in Matrix ReqYesAI drafts training quizzesYesLMS quizzes with question pools and pass marks (Scale tier or LMS add-on)
FDA MDR or EU vigilance reportingNot confirmed yetAdverse-event complaint types, but no documented MDR or vigilance reportsPartly or add-onIncidents record whether they are serious and reportable; no MDR or EU vigilance report formsPartly or add-onReportability assessment on a marketing page onlyPartly or add-onReportability decision and report task; no eMDR submissionNot confirmed yetNo FDA MDR or EU vigilance reporting feature found
AI featuresYesAI agents for CAPA drafts, complaint trends and quality reviewYesAI drafting of QMS and technical documents; data goes to OpenAI only when you click generateYesMatrix Mind, AI design tools, compliance checkerYesGreenlight Guru AI: search, answers, summaries; ISO 42001Not confirmed yetNo AI features documented; the new owner plans to add AI

Frequently asked questions

What are the best Ketryx alternatives?
It depends on why you’re leaving. Greenlight Guru is a full device eQMS with IEC 62304-aligned release management and Jira and GitHub sync. Matrix Requirements pairs traceability and native developer-tool links with a separate eQMS for suppliers and audits. Orcanos keeps requirements, risk, tests and quality records in one database. Formwork is a low-cost option for early startups, without developer-tool integrations.
Is there a Ketryx alternative with published prices?
Yes. Matrix One publishes per-user prices for Matrix Req and Matrix Quality; together they come to about $21.8k a year for a 10-person team (September 2026). Formwork publishes flat prices, with 499 € a month plus VAT for unlimited users. Greenlight Guru publishes an entry price of $12,000 a year, but Vendr reports a median of $43,989.
Which Ketryx alternative covers suppliers and internal audits?
Greenlight Guru’s eQMS covers suppliers, audits, CAPA, complaints and nonconformances. Matrix One covers suppliers and audits in Matrix Quality, a separate Salesforce-based product. Orcanos describes supplier and audit features only on marketing pages, and Formwork documents suppliers but has no internal audit planning.
Which Ketryx alternative still connects to Jira and Git?
Matrix Requirements links to Jira, GitHub, GitLab and Azure DevOps, and Greenlight Guru syncs with Jira and GitHub. Orcanos documents Jira only through Zapier. Formwork has no Jira or Git integration, by design.
When should I stay with Ketryx?
Stay if your main job is generating design history, trace and risk records from Jira and Git, and you already run another eQMS for suppliers, audits and production. Ketryx’s platform is certified to IEC 62304, ISO 13485 and ISO 14971, and a validation package ships with every major and minor release.