Orcanos alternatives for medical device companies

The best alternatives to Orcanos, ranked by overall score.

By · Updated

Orcanos puts design controls and quality records in one database, and its engineering side is well documented. The reasons device teams look elsewhere are mostly about what you can’t check before a sales call: prices, trial access, hosting terms, and how deep the quality workflows go. Here’s what our evidence shows, which alternatives fit which situation, and when Orcanos remains the better pick.

Why teams look for Orcanos alternatives

No current prices. Orcanos published prices until 2021, then removed them.12 In 2024 the plans shrank: Essentials went from 10 included users to 5, and API access moved up to Professional.23 The terms let Orcanos raise prices at the end of a billing cycle, with no cap.4

No free trial, and key features on the top plan. We found no free trial; the site offers a live demo.5 API access, the Service Center for customer complaints and a sandbox are only on the Professional plan.6

Thin documentation for quality workflows. Supplier, audit and nonconformance workflows appear on marketing pages, not in the help center.789 We found nothing for UDI, eMDR or EU vigilance reporting.

Hosting terms you can’t read. The vendor says data stays in an EU or US zone, but doesn’t name the country.1011 Its terms refer to a DPA with subprocessors, but we found no public copy or subprocessor list. Closing an account deletes its data, with no exit-export clause.4

Ease of use. Recent G2 reviewers say the interface could be more user-friendly and that the admin side needs deep understanding.12 Several Capterra reviewers report slowness, for example in tree views.13

Developer tools. Jira connects through Zapier. GitHub and Azure DevOps are named on the homepage but not documented.145

Which alternative fits your situation

Matrix Requirements publishes prices: Matrix Req Team Plus plus ten Matrix Quality licences comes to about $21.8k a year (September 2026).1516 You can start a Matrix Req trial yourself, with all features and no credit card.17 It links issues to Jira, GitHub, GitLab and Azure DevOps, and its template package covers IEC 62304.1819 Matrix Quality has recorded walkthroughs of supplier evaluation, audits and complaint handling.202122 The catch is that this is two products on different platforms, and Matrix Quality’s hosting region isn’t documented.16

Your engineers live in Jira and Git: Ketryx

Ketryx syncs requirements, software items, tests and risks from Jira, Git and test tools and generates the design history file from them.23 You can start a 30-day trial without a credit card, and the DPA is public.2425 A full project exports as a JSON archive.26 Paid plans are contact-sales, and we found no documented supplier, internal audit or production record workflows, so it works best next to an existing eQMS.2728

You want documented complaint handling and a clear exit: Greenlight Guru

Greenlight Guru complaint handling includes a step for deciding whether a regulatory report is needed, which creates a task to prepare the FDA report.29 Suppliers get risk levels, and a policy matrix suggests the required documents, audits and monitoring.30 You can export quality records in standard formats without paying for services, and you have 90 days after the contract ends to request an export.3132 It also offers IEC 62304-aligned release management with Jira and GitHub sync.3334 The entry price is $12,000 a year, but Vendr reports a median of $43,989, and there’s no free trial.313536

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

Formwork publishes its full price list: 499 € a month plus VAT for unlimited users, and a free tier you can sign up for yourself.3738 Each product records its IEC 62304 safety class, and requirements link to risk controls and tests.3940 Supplier re-evaluation follows each supplier’s criticality, and documents and records export as PDF or Markdown at any time.4142 It doesn’t solve every Orcanos gap. Complaints are logged as incidents with no documented investigation step, there’s no internal audit planning, and there’s no Jira or Git integration.434445 The vendor has no ISO 27001 certification, and Formwork has 2 reviews on G2, too few for a rating.4647

When to stay with Orcanos

Orcanos has real strengths, and switching takes work:

  • One database. Requirements, risks, tests, CAPAs and complaints share one data model, with no integration to maintain.5
  • Documented traceability. The help center documents risk items linked to mitigating requirements and tests, traceability reports that expose missing tests, and flags on linked items when something changes.484950
  • Generated documents. The risk management file and design documents are generated to Word from live data, using your own templates.5152
  • Hardware support. Engineering change orders and electronic device history records are documented.5354
  • Included services. Every plan lists a validation package, basic onboarding and business-hours chat support.6
  • Security and support. Orcanos is certified to ISO 27001:2022, and G2 reviewers rate its quality of support 8.9/10 (Sep 2026).5512

  1. Orcanos: Pricing, archived 27 Sep 2020 and 3 Mar 2021. Vendor price list via the Wayback Machine, checked 4 Oct 2026. ↩︎

  2. Orcanos: Pricing, archived 29 Jan 2024 and 14 Jun 2024. Vendor website via the Wayback Machine, checked 1 Oct 2026. ↩︎ ↩︎

  3. Orcanos: Pricing, archived 14 Dec 2024. Vendor website via the Wayback Machine, checked 1 Oct 2026. ↩︎

  4. Orcanos: Terms of service. Vendor terms, effective Dec 2025, checked 1 Oct 2026. ↩︎ ↩︎

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

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

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

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

  9. Orcanos: Nonconformance management. Vendor marketing page, checked 30 Sep 2026. ↩︎

  10. Orcanos: Privacy policy. Vendor website, checked 1 Oct 2026. ↩︎

  11. Orcanos: GDPR compliance. Vendor website, checked 30 Sep 2026. ↩︎

  12. G2: Orcanos reviews. Review site; ratings and page 1 review texts checked in a browser 30 Sep 2026. ↩︎ ↩︎

  13. Capterra: Orcanos (ALM 2.0) reviews. Review site; rating checked in a browser 30 Sep 2026, review texts read via a fetch tool. ↩︎

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

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

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

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

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

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

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

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

  22. Simploud Academy: Complaint handling (webinar). Help center video, published 4 Feb 2026. ↩︎

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

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

  25. Ketryx: Data Processing Addendum. Vendor legal page, effective 24 Jun 2026. ↩︎

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

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

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

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

  30. Greenlight Guru: Supplier management software. Vendor website, checked 29 Sep 2026. ↩︎

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

  32. Greenlight Guru: Master subscription agreement. Vendor legal page, updated 26 Aug 2026, checked 1 Oct 2026. ↩︎

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

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

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

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

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

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

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

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

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

  42. No lock-in, ever: Formwork batch export, archived 25 Apr 2025. Vendor release article, updated 1 Oct 2024. ↩︎

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

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

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

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

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

  48. Orcanos help center: FMEA risk management. Help center, checked 30 Sep 2026. ↩︎

  49. Orcanos help center: Traceability matrix. Help center, checked 30 Sep 2026. ↩︎

  50. Orcanos help center: Suspicious items. Help center, checked 30 Sep 2026. ↩︎

  51. Orcanos help center: Generate risk management file. Help center, checked 30 Sep 2026. ↩︎

  52. Orcanos help center: Online document generator. Help center, checked 30 Sep 2026. ↩︎

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

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

  55. Orcanos: Security center. Vendor website, checked 30 Sep 2026. ↩︎

Why people switch: Prices are not published, and supplier, audit, nonconformance and complaint workflows are described mainly on marketing pages rather than in the help center. Read our Orcanos 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

    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
  8. 8

    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
    Read the Ketryx review Ketryx 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

Orcanos vs the top alternatives

OrcanosOpenRegulatory FormworkMatrix Requirements (Matrix One)Greenlight GuruCognidox
Built-in document editorPartly or add-onRich-text items for design documents; SOPs are uploaded Office filesYesRich-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 DocsYesCheck out and edit in Word or Excel; Word add-on for live fields (Windows)Partly 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-on'Out of the box templates' and pre-built processes; no SOP library foundYesOpenRegulatory'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 integrationPartly or add-onJira via Zapier documented; GitHub and Azure DevOps only namedNoVendor 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 compliance checks, software traceability, test automation APIYesSafety 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 includedYes'Full Validation Package' listed on every planYesPre-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 APIYesDocumented REST and SOAP API; Professional plan onlyPartly 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)YesSAML 2.0, Office 365, Google, Okta; Essentials plan and upPartly 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 yetCustomer portal exists; no supplier portal 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-understand tasks only; 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 yetNo FDA MDR or EU vigilance reporting foundPartly 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 featuresYesAsk Paul assistant (GPT-5), opt-inYesAI 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 Orcanos alternatives?
Matrix Requirements if you want published prices, a self-serve trial and native developer-tool links. Ketryx if your engineers work in Jira and Git and you already have an eQMS. Greenlight Guru if you want a full device eQMS with a documented complaint workflow. Formwork if a flat low price matters most and you can accept its gaps.
Is there an Orcanos alternative with published prices?
Yes. Matrix One publishes per-user prices: Matrix Req Team Plus plus ten Matrix Quality licences comes to about $21.8k a year (September 2026). Formwork publishes 499 € a month plus VAT for unlimited users. Greenlight Guru publishes an entry price of $12,000 a year, though Vendr reports a median of $43,989. Orcanos took its price list down after 2021.
Which Orcanos alternative has a free trial?
Ketryx offers a 30-day trial without a credit card, and you can start a Matrix Req trial yourself. Formwork has a free tier you can sign up for. Greenlight Guru, like Orcanos, has no free trial.
Which Orcanos alternative integrates natively with Jira and Git?
Ketryx syncs from Jira, GitHub, GitLab, Bitbucket and Azure DevOps, and Matrix Req links to Jira, GitHub, GitLab and Azure DevOps. Greenlight Guru syncs with Jira and GitHub. Orcanos documents Jira only through Zapier, and Formwork has no Jira or Git integration.
When should I stay with Orcanos?
Stay if you want requirements, risk, tests and quality records in one database instead of two tools joined by an integration. Orcanos lists onboarding and a validation package on every plan, is certified to ISO 27001:2022, and gets 8.9/10 for quality of support on G2.