# Best Ketryx alternatives for medical device companies (2026)

Source: https://bestqmssoftware.com/alternatives/ketryx-alternatives/
By Tom Muller, updated October 5, 2026
Part of Best QMS Software (https://bestqmssoftware.com/). Method: https://bestqmssoftware.com/how-we-rank/



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.[^kx-llms] Its templated QMS includes SOPs for internal audit and purchasing, but those are documents, not system features.[^kx-iso13485] Ketryx itself describes the platform as a bridge between engineering tools and your existing eQMS.[^kx-meddev] The complaint workflow has no documented reportability step, and the documented nonconformance workflow covers software anomalies only.[^kx-wi07][^kx-wi06]

**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".[^kx-pricing] We found no price paid in reviews, forums or benchmark sites. The terms let Ketryx raise fees at renewal, with no cap.[^kx-terms]

**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.[^kx-trust]

**Little independent feedback.** Ketryx has 2 reviews on G2 and no Capterra listing.[^kx-g2] 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.[^kx-reddit-koojo][^kx-reddit-pm][^kx-reddit-eqms]

## Which alternative fits your situation

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

[Greenlight Guru](/reviews/greenlight-guru/) covers document control, change control, training, suppliers, audits, CAPA, complaints and nonconformances, next to requirements, design controls and ISO 14971 risk.[^gg-pricing] For software it offers IEC 62304-aligned release management, Jira and GitHub sync, and SBOM scanning.[^gg-ultralight][^gg-samd] Complaint handling includes a step for deciding whether a regulatory report is needed.[^gg-complaints] It publishes an entry price of $12,000 a year, with implementation quoted separately, but Vendr reports a median of $43,989 a year.[^gg-pricing][^gg-vendr] We found no free trial.[^gg-tourpage]

### You want traceability plus supplier and audit workflows: Matrix Requirements

[Matrix Requirements](/reviews/matrix-requirements/) documents configurable traceability rules and issue links to Jira, GitHub, GitLab and Azure DevOps.[^mx-trace][^mx-git] Its SxMD template package covers IEC 62304 on Company and Enterprise plans.[^mx-sxmd] Supplier and audit workflows come from a second product, Matrix Quality, which runs on Salesforce.[^mx-supplier][^mx-audit] Both products publish prices: Matrix Req Team Plus plus ten Matrix Quality licences comes to about $21.8k a year (September 2026).[^mx-list2026][^mx-quality] You can start a Matrix Req trial yourself.[^mx-trial] Matrix Quality's hosting region isn't documented.[^mx-quality]

### You want engineering and quality in one database: Orcanos

In [Orcanos](/reviews/orcanos/), requirements, risk, tests, CAPAs and quality records share one database, so there's no integration to maintain.[^or-home] Software teams get IEC 62304 compliance checks that take a software safety class, and test automation through the API.[^or-insights][^or-automation] Hardware teams get engineering change orders and electronic device history records.[^or-eco][^or-edhr] The trade-offs: Jira connects only through Zapier, prices aren't published, and we found no free trial.[^or-jira][^or-pricing][^or-home] Supplier and audit features appear only on marketing pages.[^or-supplier][^or-audit]

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

[Formwork](/reviews/formwork/) publishes flat prices: 499 € a month plus VAT for unlimited users, and a free tier you can sign up for yourself.[^fw-pricing][^fw-signup] Each product records its IEC 62304 safety class, and requirements link to risk controls and tests.[^fw-techdoc][^fw-swr] Supplier re-evaluation follows each supplier's criticality.[^fw-suppliers] It has gaps a Ketryx user will notice. There's no Jira or Git integration, by design.[^fw-landing] Complaints are logged as incidents with no documented investigation step, and we found no internal audit planning.[^fw-incidents][^fw-nc] The vendor has no ISO 27001 certification, and Formwork has 2 reviews on G2, too few for a rating.[^fw-audits][^fw-g2]

## 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.[^kx-dhf] Release gates can block a release until traceability is complete.[^kx-rel211]
- **Certified platform.** The platform itself is certified to IEC 62304, ISO 13485 and ISO 14971 by UL Solutions.[^kx-certs] A validation package comes with every major and minor release.[^kx-valpkg]
- **SOUP tracking.** It tracks SOUP through a software bill of materials and emails users about new vulnerabilities in released versions.[^kx-rel211]
- **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.[^kx-signup][^kx-man13]
- **Security.** Ketryx holds ISO/IEC 27001:2022 and SOC 2 Type 2.[^kx-certs]

[^kx-llms]: [Ketryx: AI-readable site index](https://llm.ketryx.com/llms.txt). Vendor website mirror (743 pages searched), checked 30 Sep 2026.
[^kx-iso13485]: [Ketryx help center: How can I use Ketryx for ISO 13485 compliance?](https://support.ketryx.com/hc/en-us/articles/34352253786893-How-can-I-use-Ketryx-for-ISO-13485-compliance) Help center, checked 30 Sep 2026.
[^kx-meddev]: [Ketryx: Medical devices](https://www.ketryx.com/industries/medical-devices). Vendor website, checked 30 Sep 2026.
[^kx-wi07]: [Ketryx docs: WI-07 Complaint (archived)](https://web.archive.org/web/20240422191706/https://docs.ketryx.com/work-instructions/wi-07-complaint). Product documentation, captured 22 Apr 2024.
[^kx-wi06]: [Ketryx docs: WI-06 Anomaly (archived)](https://web.archive.org/web/20240422193517/https://docs.ketryx.com/work-instructions/wi-06-anomaly). Product documentation, captured 22 Apr 2024.
[^kx-pricing]: [Ketryx: Pricing](https://www.ketryx.com/pricing). Vendor website, checked 4 Oct 2026.
[^kx-terms]: [Ketryx: Terms of Service](https://www.ketryx.com/terms). Vendor terms, checked 1 Oct 2026.
[^kx-trust]: [Ketryx Trust Center](https://trust.ketryx.com). Vendor trust center, checked in a browser 30 Sep 2026.
[^kx-g2]: [G2: Ketryx Connected Lifecycle Management reviews](https://www.g2.com/products/ketryx-connected-lifecycle-management/reviews). Review site, checked in a browser 30 Sep 2026.
[^kx-reddit-koojo]: [Reddit r/MedicalDevices: comment by a Ketryx user](https://www.reddit.com/r/MedicalDevices/comments/1jgi5p0/any_quality_engineers_using_ketryx_or_greenlight/mjm72t1/). Community post, Mar 2025.
[^kx-reddit-pm]: [Reddit r/ProductManagement: comment by a Ketryx user](https://www.reddit.com/r/ProductManagement/comments/1lprteu/top_5_things_i_learned_in_10_years_of_product/n0yrc03/). Community post, Jul 2025.
[^kx-reddit-eqms]: [Reddit r/MedicalDevices: Ketryx for eQMS](https://www.reddit.com/r/MedicalDevices/comments/1w8i2dy/ketryx_for_eqms/). Community post, Sep 2026.
[^gg-pricing]: [Greenlight Guru: Quality pricing and packages](https://www.greenlight.guru/quality-pricing). Vendor website, checked 29 Sep 2026.
[^gg-ultralight]: [Greenlight Guru: Ultralight eQMS](https://www.greenlight.guru/ultralight-eqms). Vendor website, checked 29 Sep 2026.
[^gg-samd]: [Greenlight Guru: Product development for SiMD/SaMD](https://www.greenlight.guru/productdevelopment-simd-samd). Vendor website, checked 29 Sep 2026.
[^gg-complaints]: [Greenlight Guru: Complaint management software](https://www.greenlight.guru/complaint-management-software). Vendor website, checked 29 Sep 2026.
[^gg-vendr]: [Vendr: Greenlight Guru pricing](https://www.vendr.com/marketplace/greenlight-guru). Price benchmark, checked 29 Sep 2026.
[^gg-tourpage]: [Greenlight Guru: Quality management software product tour](https://www.greenlight.guru/quality-management-software-product-tour). Vendor website, checked 29 Sep 2026.
[^mx-trace]: [Matrix One user manual: Traceability](https://docs.matrixreq.com/en/articles/234192-traceability). Help center, checked 29 Sep 2026.
[^mx-git]: [Matrix One user manual: GitHub and GitLab integration](https://docs.matrixreq.com/en/articles/240976-github-and-gitlab-integration-with-matrix-requirements). Help center, checked 29 Sep 2026.
[^mx-sxmd]: [Matrix One blog: SxMD templates package](https://matrixone.health/blog/sxmd-templates-package). Vendor blog, published 2 Oct 2023.
[^mx-supplier]: [Simploud Academy: Suppliers with portal (session recording)](https://support.simploud.com/suppliers-with-portal/). Help center video, checked 29 Sep 2026.
[^mx-audit]: [Simploud Academy: Audit management (webinar)](https://support.simploud.com/audit-managements/). Help center video, published 9 Dec 2025.
[^mx-list2026]: [Matrix One: Company Plus plan page](https://matrixone.health/pricing/plans/company-plus). Unlinked vendor price page, updated Feb 2026, checked 29 Sep 2026.
[^mx-quality]: [Matrix One: Matrix Quality product page, ROI calculator and FAQ](https://matrixone.health/products/matrix-quality). Vendor website, checked 29 Sep 2026.
[^mx-trial]: [Matrix One: Free trial](https://matrixone.health/trial). Vendor website, checked 29 Sep 2026.
[^or-home]: [Orcanos: homepage](https://www.orcanos.com/). Vendor website, checked 30 Sep 2026.
[^or-insights]: [Orcanos help center: Audit Insights (compliance and governance)](https://help.orcanos.com/knowledgebase/compliance-and-governance/). Help center, checked 30 Sep 2026.
[^or-automation]: [Orcanos help center: How to automate tests](https://help.orcanos.com/knowledgebase/how-to-automate-the-tests-in-orcanos/). Help center, checked 30 Sep 2026.
[^or-eco]: [Orcanos help center: ECO](https://help.orcanos.com/knowledgebase/eco/). Help center, updated 1 Feb 2026.
[^or-edhr]: [Orcanos help center: Adding a new e-DHR item](https://help.orcanos.com/knowledgebase/adding-new-e-dhr-item/). Help center, checked 30 Sep 2026.
[^or-jira]: [Orcanos help center: Jira integration through Zapier](https://help.orcanos.com/knowledgebase/jira-to-orcanos-integration-through-zapier/). Help center, updated 13 Apr 2026.
[^or-pricing]: [Orcanos: Pricing](https://www.orcanos.com/pricing). Vendor website, checked 4 Oct 2026.
[^or-supplier]: [Orcanos: Supplier qualification management](https://www.orcanos.com/supplier-qualification-management-system). Vendor marketing page, checked 30 Sep 2026.
[^or-audit]: [Orcanos: Audit management](https://www.orcanos.com/audit-management-software-system). Vendor marketing page, checked 30 Sep 2026.
[^fw-pricing]: [Formwork pricing, archived 3 Oct 2026](https://web.archive.org/web/20261003032601/https://openregulatory.com/pricing). Vendor website (Wayback Machine), read 4 Oct 2026; also checked in a browser 1 Oct 2026.
[^fw-signup]: [Formwork sign-up page](https://app.openregulatory.com/users/sign_up). Vendor website, checked 4 Oct 2026.
[^fw-techdoc]: [Documenting your medical device in Formwork, archived 25 Apr 2025](https://web.archive.org/web/20250425091145/https://openregulatory.com/documenting-your-medical-device-in-formwork/). Vendor documentation, updated 1 Oct 2024.
[^fw-swr]: [Software requirements and design inputs in Formwork, archived 25 Apr 2025](https://web.archive.org/web/20250425090838/https://openregulatory.com/software-requirements-and-design-inputs-in-formwork/). Vendor documentation, updated 1 Oct 2024.
[^fw-suppliers]: [Formwork Manual: Suppliers](https://openregulatory.com/formwork/manual/suppliers). Vendor documentation, checked 1 Oct 2026.
[^fw-landing]: [Formwork product page and FAQ, archived 19 Feb 2026](https://web.archive.org/web/20260219065032/https://openregulatory.com/formwork). Vendor website (Wayback Machine), checked 4 Oct 2026.
[^fw-incidents]: [Formwork Manual: Incidents & Complaints, archived 4 Oct 2026](https://web.archive.org/web/20261004123314/https://openregulatory.com/formwork/manual/incidents-complaints). Vendor documentation, published 9 Sep 2026.
[^fw-nc]: [Formwork Manual: Non Conformities, archived 4 Oct 2026](https://web.archive.org/web/20261004123513/https://openregulatory.com/formwork/manual/non-conformities). Vendor documentation, published 9 Sep 2026.
[^fw-audits]: [Formwork Manual: Compliance & Passing Audits, archived 4 Oct 2026](https://web.archive.org/web/20261004123605/https://openregulatory.com/formwork/manual/compliance-and-passing-audits). Vendor documentation, published 22 Jan 2026.
[^fw-g2]: [G2: Formwork eQMS reviews](https://www.g2.com/products/formwork-eqms/reviews). Review site, checked 30 Sep 2026.
[^kx-dhf]: [Ketryx docs: How to generate the Design History File for your medical device (archived)](https://web.archive.org/web/20251015061057/https://docs.ketryx.com/how-to-guides/how-to-generate-the-design-history-file-for-your-medical-device). Product documentation, captured 15 Oct 2025.
[^kx-rel211]: [Ketryx: Ketryx 2.11 release](https://www.ketryx.com/blog/ketryx-2-11). Release notes, published 27 Jan 2025.
[^kx-certs]: [Ketryx: Certifications](https://www.ketryx.com/about/certifications). Vendor website, checked 30 Sep 2026.
[^kx-valpkg]: [Ketryx: Inside Ketryx's customer validation package](https://www.ketryx.com/blog/inside-ketryxs-customer-validation-package). Vendor blog, published 12 Dec 2025.
[^kx-signup]: [Ketryx: Sign up for a free trial](https://app.ketryx.com/auth/signup). Vendor website, checked 30 Sep 2026.
[^kx-man13]: [Ketryx docs: MAN-13 Data Export (archived)](https://web.archive.org/web/20250428075013/https://docs.ketryx.com/manuals/man-13-data-export). Product documentation, captured 28 Apr 2025.


Why people switch from Ketryx: We found no documented supplier, internal audit, DMR/DHR or vigilance-reporting workflows, so most device companies will run it next to another eQMS. Review: https://bestqmssoftware.com/reviews/ketryx/

## Alternatives ranked by overall score

1. [OpenRegulatory Formwork](https://bestqmssoftware.com/reviews/formwork/): 7.8/10, $7k/yr. Best for: 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.
2. [Matrix Requirements (Matrix One)](https://bestqmssoftware.com/reviews/matrix-requirements/): 7.5/10, from $22k/yr. Best for: You build software or software-heavy devices and need design controls, risk and test traceability tied to your QMS.
3. [Greenlight Guru](https://bestqmssoftware.com/reviews/greenlight-guru/): 7.4/10, from $12k/yr. Best for: 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.
4. [Cognidox](https://bestqmssoftware.com/reviews/cognidox/): 7.2/10, from $8k/yr. Best for: 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.
5. [SimplerQMS](https://bestqmssoftware.com/reviews/simplerqms/): 7.1/10, from $17.5k/yr. Best for: 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.
6. [Qualio](https://bestqmssoftware.com/reviews/qualio/): 6.8/10, est. $12–30k/yr. Best for: 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.
7. [Orcanos](https://bestqmssoftware.com/reviews/orcanos/): 6.7/10, pricing on request. Best for: 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.
8. [Arena QMS](https://bestqmssoftware.com/reviews/arena-qms/): 6.6/10, est. $12–25k/yr. Best for: 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.
9. [Ideagen Quality Management](https://bestqmssoftware.com/reviews/ideagen-quality/): 6.4/10, est. $22–29k/yr. Best for: 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.
10. [Scilife](https://bestqmssoftware.com/reviews/scilife/): 6.3/10, pricing on request. Best for: You run a GMP-regulated pharma, biotech or combined device and pharma operation and want an easy-to-learn eQMS with validation documents included.
11. [Dot Compliance](https://bestqmssoftware.com/reviews/dot-compliance/): 5.9/10, pricing on request. Best for: 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.
12. [ETQ Reliance (Octave Reliance)](https://bestqmssoftware.com/reviews/etq-reliance/): 5.1/10, pricing on request. Best for: 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.
13. [MasterControl](https://bestqmssoftware.com/reviews/mastercontrol/): 5.1/10, est. $25–72k/yr. Best for: 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.
14. [Qualityze](https://bestqmssoftware.com/reviews/qualityze/): 4.9/10, pricing on request. Best for: 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.