# Free QMS software for medical devices (2026)

Source: https://bestqmssoftware.com/free-qms-software/
By Tom Muller, updated October 30, 2026
Part of Best QMS Software (https://bestqmssoftware.com/). Method: https://bestqmssoftware.com/how-we-rank/


## Is there free QMS software for medical devices?

Yes, but not the kind that takes a company through certification at no cost. Of the systems we reviewed, two have a free plan, and both come with conditions. Formwork's Community Edition is capped at 10 documents and 10 records,[^fw-pricing] and Ketryx's Free plan is only for pre-market companies that raised less than $2 million.[^ketryx-pricing] We found no maintained open-source eQMS built for medical devices. The free route most small device companies actually take is a set of free QMS templates run on tools they already have, from a shared drive to GitHub.

Each option is free in a different way: a free plan saves you the licence fee for a while, open-source code saves it for good but leaves you to host and validate it, and templates save you writing time but not the work of running a QMS. Whatever you pick, ISO 13485 and, in the US, 21 CFR Part 11 still apply to the software that holds your quality records. The [last section](#what-a-free-setup-still-has-to-cover) lists what that means.

## Free plans from the systems we reviewed

**OpenRegulatory Formwork.** The Community Edition is "free forever" for 5 users, with up to 10 documents and 10 records and no support.[^fw-pricing] That's enough to look around, not to run a QMS: a typical ISO 13485 template set has dozens of procedures on its own.[^or-templates] Formwork's FAQ answers "Can we pass an ISO 13485 audit with the free Formwork Community Edition?" with "No," and recommends upgrading before the audit.[^fw-faq] Starter costs $119 a month for 5 users without usage limits, but releasing product documentation and the validation report come only with QMS + Techdoc at $599 a month.[^fw-pricing] OpenRegulatory, which makes Formwork, also publishes the free templates discussed below.

**Ketryx.** The Free plan costs $0 a year and is "for pre-market companies starting to build validated systems that have raised less than $2 million in funding".[^ketryx-pricing] The current page lists no plan limits; in 2024 the Free plan allowed up to 4 users.[^ketryx-2024] Ketryx is a lifecycle layer over Jira and Git as much as an eQMS, so it suits software teams best; see the [Ketryx review](/reviews/ketryx/).

**Scilife** had a free plan in March 2025, with unlimited users, up to 20 documents and 5 trainings.[^scilife-2025] It's no longer on the pricing page, which shows how quickly free plans can change. Check the terms on the day you sign up.

Free trials are more common than free plans. Ketryx offers a 30-day all-access trial without a credit card,[^ketryx-trial] and you can start a Matrix Req trial yourself.[^matrix-trial] Cognidox, Arena, QT9, SimplerQMS, Scilife and Dot Compliance offer trials after a request form or a call. The full list is [below](#how-to-try-each-system-we-reviewed).

## Open-source QMS software

We searched GitHub and the web for open-source QMS software that a device company could host itself.[^gh-search] There are a few candidates, and none of them is a maintained ISO 13485 eQMS.

- **OpenQMS.net** by C-realize is the closest. It is a self-hosted web application, dual-licensed under the AGPL or a commercial licence,[^openqms-repo] with training records, versioned documents approved by entering credentials, and change and deviation events.[^openqms-docs] The vendor says it is "designed and built to meet biopharmaceutical quality standards like GXP, Part 11, Annex 11".[^openqms-site] Its product page and documentation don't mention ISO 13485 or the EU MDR, the public repository has six commits since 2022 and no releases, and audits and risk management are part of a paid "business level" tier.[^openqms-repo][^openqms-site]
- **Odoo** is open source in its Community edition, but its Quality, Documents and Sign apps are Enterprise-only.[^odoo-editions]
- **The OCA management-system add-ons for Odoo** are AGPL-licensed and actively maintained, with modules for a quality manual, procedures, management reviews, audits, nonconformities and corrective actions.[^oca] They are written for generic management systems in the ISO 9001 style; we found no ISO 13485 content in the repository.[^oca]
- **ERPNext** has a GPL-licensed quality module with procedures, reviews, actions and nonconformances, but its documentation frames quality management around "production and procurement processes", not a device QMS.[^erpnext]
- The other medical device projects we found are early prototypes with one or two contributors, and one says of itself that it is "not yet implemented, certified, compliant, or production-ready".[^open-eqms]

If you want open-source software, the realistic choice is a general tool (an ERP, a document management system or GitHub itself) that you configure, document and validate yourself.

## Free QMS templates and the tools you already have

Many startups write their QMS from a free template set, keep the documents in Google Drive, Microsoft 365 or a Git repository, and run the processes by hand. The template sets differ more in their licences than in their content.

| Template set | Covers | Licence | Last updated |
|---|---|---|---|
| [OpenRegulatory templates](https://github.com/openregulatory/templates) | ISO 13485 QMS, IEC 62304, ISO 14971, IEC 62366, clinical evaluation | CC BY-NC-SA 4.0 (non-commercial) | January 2025 |
| [GSTT QMS template](https://github.com/GSTT-CSC/QMS-Template) | QMS for software and AI devices, run in GitHub | Apache 2.0 for the repository; 17 files carry OpenRegulatory's template notice | August 2025 |
| [DearAuditor Open QMS Baseline](https://github.com/AliakseiT/dearauditor-qms-baseline) | Quality manual, 23 SOPs and 2 work instructions, run in GitHub | CC BY-SA 4.0 for documents, Apache 2.0 for code | September 2026 |
| [QARA PULSE](https://github.com/abonnet-qarapulse/qara-pulse-eqms) | Git-based QMS for software and AI devices only | Apache 2.0 (open core) | February 2026 |

**OpenRegulatory's templates** are the best known. The site offers them "for free as Word, PDF, Markdown or HTML files", including 37 ISO 13485 templates,[^or-templates] and you can download them without an account or an email address (October 2026).[^or-download] The site calls them "open-source", but the licence is Creative Commons Attribution-NonCommercial-ShareAlike 4.0, and the licence page says "You may not use the templates for commercial purposes."[^or-licence] Whether a device company using them internally counts as commercial use is a legal question we can't answer; read the licence before you build on them. The repository's last content change was in January 2025.[^or-repo] OpenRegulatory also makes Formwork, and its template pages promote it.[^or-collection]

**The GSTT template** is an empty copy of the QMS used by the Clinical Scientific Computing team at Guy's and St Thomas' NHS Foundation Trust. Its README says that QMS "has survived 18 internal audits and 3 external ISO 13485 audits by two different notified bodies in the UK", which is the team's own statement.[^gstt] Document control runs on GitHub issues, pull requests with reviewers, and releases.[^gstt-doc] The repository is licensed under Apache 2.0, but the team says many SOPs come from OpenRegulatory's templates, and 17 files still carry OpenRegulatory's template copyright notice,[^gstt][^gstt-doc] so the non-commercial licence above may apply to those files.

**DearAuditor's baseline** is the most complete permissively licensed set we found. It runs the QMS in GitHub, with a signature service that combines a GitHub login with a six-digit PIN.[^dearauditor-sign] It says it "is not, by itself, an adopting company's operational QMS",[^dearauditor] and its maintainers sell help with tailoring and IQ/OQ/PQ validation.[^dearauditor] It started in March 2026 and has two contributors.

**Vendors and consultancies** also offer free templates, but these are usually samples behind a form. Greenlight Guru's free quality manual template, its 24-item resource kit and a complaint log and form bundle made with Rook Quality Systems all ask for your name, company, work email and whether you want a demo before you get the files.[^gg-templates] Archimedic, a US device development firm, offers 33 free design and development forms under the name OpenQMS (not related to OpenQMS.net), from user needs and FMEA to CAPA, nonconformance and complaint forms. Each download asks for your first name and email, and we found no licence on its pages.[^archimedic] Advisera offers a free preview of its paid ISO 13485 toolkit after you fill in a name and email form, and says its experts will then contact you.[^advisera]

## What a free setup still has to cover

The price of the software doesn't change what the standards ask of it.

- **Document and record control.** ISO 13485 clause 4.2.4 requires documents to be controlled, and clause 4.2.5 does the same for records.[^qmsr-rule] On a shared drive that means you define and enforce review, approval, versions and retention yourself.
- **Validation of the software.** ISO 13485 asks you to validate software used in the quality management system for that use, including free tools. FDA's final guidance on Computer Software Assurance (September 2025) describes a risk-based approach to software used in production or the quality system.[^csa] Paid systems often supply a validation package; with free tools you write it.
- **The US: QMSR and Part 11.** Since 2 February 2026, the FDA's Quality Management System Regulation requires a QMS that complies with ISO 13485, which it incorporates by reference.[^qmsr] Part 11 applies to records in electronic form kept under any FDA records requirement.[^part11] It asks for validated systems and "secure, computer-generated, time-stamped audit trails" (§ 11.10); signatures that show the signer's name, the date and time and the meaning (§ 11.50) and are linked to their records (§ 11.70); signatures unique to one person, with at least two components such as an ID and a password (§ 11.100, § 11.200); and a letter certifying to FDA that your electronic signatures are legally binding (§ 11.100(c)).[^part11] A shared drive or a plain Git repository doesn't do this out of the box. See our [Part 11 software](/part-11-software/) page for how the paid systems handle it.
- **The EU.** Article 10(9) of the MDR requires a quality management system that covers a list of aspects, from risk management and clinical evaluation to corrective action.[^mdr] It doesn't say the QMS has to run in software.

## When a paid QMS becomes cheaper than free

A free setup costs time instead: tailoring the templates, building the workflows by hand, writing the validation and keeping it all current. The lowest published prices among the systems we reviewed are Formwork Starter at $119 a month for 5 users and QMS + Techdoc at $599 a month,[^fw-pricing] Cognidox from $8,000 a year and Greenlight Guru from $12,000 a year; see our [QMS pricing overview](/pricing/) for all of them. If your team spends more than a few days a month on QMS administration, compare that time with these prices before you decide that free is cheaper.

The systems below are all the ones we reviewed, grouped by how you can try them before you pay. Every system gets the same treatment, including Formwork; our [ranking method](/how-we-rank/) explains how we score trials.

[^fw-pricing]: [Formwork pricing](https://openregulatory.com/formwork/pricing). Vendor website, checked in a browser 1 Oct 2026; see our [Formwork review](/reviews/formwork/).
[^fw-faq]: [Formwork product page and FAQ, archived 19 Feb 2026](https://web.archive.org/web/20260219065032/https://openregulatory.com/formwork). Vendor website (Wayback Machine), checked 1 Oct 2026.
[^ketryx-pricing]: [Ketryx pricing](https://www.ketryx.com/pricing). Vendor website, checked 30 Sep 2026.
[^ketryx-2024]: [Ketryx pricing, archived 16 Sep 2024](https://web.archive.org/web/20240916065207/https://www.ketryx.com/pricing). Vendor website (Wayback Machine), checked 30 Sep 2026.
[^ketryx-trial]: [Ketryx: Sign up for a free trial](https://app.ketryx.com/auth/signup). Vendor website, checked 30 Sep 2026.
[^matrix-trial]: [Matrix One: Free trial](https://matrixone.health/trial). Vendor website, checked 29 Sep 2026.
[^scilife-2025]: [Scilife pricing, archived 23 Mar 2025](https://web.archive.org/web/20250323143549/https://www.scilife.io/price). Vendor website (Wayback Machine), checked 30 Sep 2026.
[^gh-search]: GitHub repository searches for "eqms", "qms iso 13485", "medical device qms", "iso13485" and "openqms", plus web searches, 13 Oct 2026. No medical device QMS application we found had more than 16 stars.
[^openqms-repo]: [C-realize/OpenQMS on GitHub](https://github.com/C-realize/OpenQMS): README (licence), commit history and releases. Checked 13 Oct 2026.
[^openqms-docs]: [OpenQMS.net documentation](https://www.c-realize.com/docs), last revised 16 Sep 2023. Vendor documentation, checked 13 Oct 2026.
[^openqms-site]: [C-realize: QMS](https://www.c-realize.com/qms). Vendor website, checked 13 Oct 2026.
[^odoo-editions]: [Odoo: Community vs Enterprise editions](https://www.odoo.com/page/editions). Vendor website, checked 13 Oct 2026.
[^oca]: [OCA management-system](https://github.com/OCA/management-system), including the [mgmtsystem_quality README](https://github.com/OCA/management-system/blob/18.0/mgmtsystem_quality/README.rst). Odoo Community Association, checked 13 Oct 2026.
[^erpnext]: [ERPNext documentation: Quality management](https://docs.frappe.io/erpnext/user/manual/en/quality-management) and [quality module source](https://github.com/frappe/erpnext/tree/develop/erpnext/quality_management/doctype). Frappe, checked 13 Oct 2026.
[^open-eqms]: [dromation/open-eqms on GitHub](https://github.com/dromation/open-eqms), README. Checked 13 Oct 2026.
[^or-templates]: [OpenRegulatory: Templates, archived 21 May 2025](https://web.archive.org/web/20250521181258/https://openregulatory.com/templates/). Vendor website (Wayback Machine), checked 13 Oct 2026.
[^or-download]: [OpenRegulatory: SOP Document and Record Control](https://openregulatory.com/document_templates/sop-document-and-record-control). Vendor website, downloaded without signing in, 17 Oct 2026.
[^or-licence]: [OpenRegulatory: Template license](https://openregulatory.com/template-license) and the repository's [LICENSE.md](https://github.com/openregulatory/templates/blob/main/LICENSE.md). Checked 17 Oct 2026.
[^or-repo]: [openregulatory/templates on GitHub](https://github.com/openregulatory/templates), commit history. Checked 13 Oct 2026.
[^or-collection]: [OpenRegulatory: ISO 13485 templates, archived 16 Dec 2025](https://web.archive.org/web/20251216094717/https://openregulatory.com/collections/iso-13485-templates). Vendor website (Wayback Machine), checked 13 Oct 2026.
[^gstt]: [GSTT-CSC/QMS-Template on GitHub](https://github.com/GSTT-CSC/QMS-Template), README. Guy's and St Thomas' NHS Foundation Trust, checked 13 Oct 2026.
[^gstt-doc]: [GSTT QMS template: Document and record control procedure](https://github.com/GSTT-CSC/QMS-Template/blob/main/CSC-PR-013-Document-Record-Control.md) and a code search of the repository for OpenRegulatory's template notice. Checked 13 Oct 2026.
[^dearauditor]: [DearAuditor Open QMS Baseline on GitHub](https://github.com/AliakseiT/dearauditor-qms-baseline), README and LICENSE. Checked 13 Oct 2026.
[^dearauditor-sign]: [DearAuditor signature worker README](https://github.com/AliakseiT/dearauditor-qms-baseline/blob/main/services/signature-worker/README.md). Checked 13 Oct 2026.
[^gg-templates]: [Greenlight Guru: Quality manual documented procedures template](https://www.greenlight.guru/downloads/quality-manual-documented-procedures-template), [24 resources for medical device QA/RA professionals](https://www.greenlight.guru/downloads/medical-device-quality-regulatory) and [complaint template bundle](https://www.greenlight.guru/downloads/complaint-template-bundle). Vendor website, checked in a browser 17 Oct 2026.
[^archimedic]: [Archimedic: OpenQMS](https://www.archimedic.com/open-qms) and its [CAPA form page](https://www.archimedic.com/CAPA-Form). Vendor website, checked 17 Oct 2026.
[^advisera]: [Advisera: ISO 13485 free preview](https://advisera.com/iso-13485-free-preview/). Vendor website, checked 13 Oct 2026.
[^qmsr-rule]: [FDA: Medical Devices; Quality System Regulation Amendments, final rule](https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments), 89 FR 7496, 2 Feb 2024, summarising ISO 13485 clauses 4.2.4 and 4.2.5. Federal Register, checked 13 Oct 2026.
[^csa]: [FDA: Computer Software Assurance for Production and Quality System Software, final guidance](https://www.federalregister.gov/documents/2025/09/24/2025-18468/computer-software-assurance-for-production-and-quality-system-software-guidance-for-industry-and). Federal Register notice, 24 Sep 2025, checked 13 Oct 2026.
[^qmsr]: [21 CFR Part 820: Quality Management System Regulation](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820). eCFR, checked 13 Oct 2026.
[^part11]: [21 CFR Part 11: Electronic records; electronic signatures](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11), §§ 11.1, 11.10, 11.50, 11.70, 11.100, 11.200. eCFR, checked 13 Oct 2026.
[^mdr]: [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj), Article 10(9). EUR-Lex, checked 1 Oct 2026.


## How to try each system we reviewed

### Free plan or a trial you start yourself

- [OpenRegulatory Formwork](https://bestqmssoftware.com/reviews/formwork/): 7.8/10. Free tier. The free Community Edition has 5 users, 10 documents and 10 records, with no support. The vendor's own FAQ says it isn't enough to pass an ISO 13485 audit. Starter ($119 a month) removes the limits, but product releases and the validation report need QMS + Techdoc ($599 a month). $7k/yr.
- [Matrix Requirements (Matrix One)](https://bestqmssoftware.com/reviews/matrix-requirements/): 7.5/10. Free trial. You can start a Matrix Req trial yourself, with all features and no credit card; the manual describes it as 14 days, extendable. Matrix Quality, the separate product with complaints, deviations and audits, has a 15-day trial on request. from $25k/yr.
- [Ketryx](https://bestqmssoftware.com/reviews/ketryx/): 6.5/10. Free trial. A $0 Free plan is open only to pre-market companies that raised under $2 million; the current page lists no limits (it was 4 users in 2024). Anyone can start a 30-day all-access trial, eQMS included, without a credit card. Pricing on request.

### Free trial after a request or a sales call

- [Cognidox](https://bestqmssoftware.com/reviews/cognidox/): 7.2/10. Free trial. 14-day trial set up by the vendor, usually after a demo. from $8k/yr.
- [SimplerQMS](https://bestqmssoftware.com/reviews/simplerqms/): 7.0/10. Free trial. Guided trial after a call; interactive tours. from $17.5k/yr.
- [Arena QMS](https://bestqmssoftware.com/reviews/arena-qms/): 6.5/10. Free trial. 10-day trial by request form, no credit card; live demo. est. $12–25k/yr.
- [QT9 QMS](https://bestqmssoftware.com/reviews/qt9-qms/): 6.5/10. Free trial. 7 days by request form, with a sales walkthrough. Pricing on request.
- [Scilife](https://bestqmssoftware.com/reviews/scilife/): 6.3/10. Free trial after a call. A free trial is advertised, but the form leads to booking a call. The free plan Scilife offered in March 2025 (up to 20 documents and 5 trainings) is no longer on its pricing page. Pricing on request.
- [Dot Compliance](https://bestqmssoftware.com/reviews/dot-compliance/): 5.8/10. Free trial on request. Vendor pre-qualifies first; demo on request. Pricing on request.

### No free trial: product tours and a live demo

- [Greenlight Guru](https://bestqmssoftware.com/reviews/greenlight-guru/): 7.4/10. No free trial. Interactive tour and live demo. from $12k/yr.
- [Qualio](https://bestqmssoftware.com/reviews/qualio/): 6.8/10. No free trial. Interactive tour and live demo. est. $12–30k/yr.
- [Intellect QMS](https://bestqmssoftware.com/reviews/intellect-qms/): 6.7/10. No free trial. Recorded video tours and live demo. from $26k/yr.
- [Orcanos](https://bestqmssoftware.com/reviews/orcanos/): 6.7/10. No free trial. Video tutorials and live demo. Pricing on request.
- [Ideagen Quality Management](https://bestqmssoftware.com/reviews/ideagen-quality/): 6.4/10. No free trial. Self-serve interactive demo and live demo. est. $22–28k/yr.
- [ZenQMS](https://bestqmssoftware.com/reviews/zenqms/): 6.0/10. No free trial. Recorded walk-through, live demo; sandbox for customers. Pricing on request.
- [ETQ Reliance (Octave Reliance)](https://bestqmssoftware.com/reviews/etq-reliance/): 5.3/10. No free trial. Recorded demo video; live demo via sales. Pricing on request.
- [Veeva Vault QMS](https://bestqmssoftware.com/reviews/veeva-vault-qms/): 5.3/10. No free trial. Recorded demos and live demo. Pricing on request.
- [MasterControl](https://bestqmssoftware.com/reviews/mastercontrol/): 5.1/10. No free trial. Recorded demos and live demo. est. $25–72k/yr.
- [TrackWise Digital](https://bestqmssoftware.com/reviews/trackwise/): 5.1/10. No free trial. Recorded demos behind a form; live demo. Pricing on request.
- [Qualityze](https://bestqmssoftware.com/reviews/qualityze/): 4.9/10. No free trial. Overview videos and a live demo; sandbox trials only in case studies. Pricing on request.
- [Enzyme](https://bestqmssoftware.com/reviews/enzyme/): 4.8/10. No free trial. Recorded demo video, live demo on request. Pricing on request.