Free QMS software for medical devices

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,¹ and Ketryx’s Free plan is only for pre-market companies that raised less than $2 million.² 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 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.¹ That’s enough to look around, not to run a QMS: a typical ISO 13485 template set has dozens of procedures on its own.³ 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.⁴ 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.¹ 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”.² The current page lists no plan limits; in 2024 the Free plan allowed up to 4 users.⁵ Ketryx is a lifecycle layer over Jira and Git as much as an eQMS, so it suits software teams best; see the Ketryx review.

Scilife had a free plan in March 2025, with unlimited users, up to 20 documents and 5 trainings.⁶ 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,⁷ and you can start a Matrix Req trial yourself.⁸ Cognidox, Arena, QT9, SimplerQMS, Scilife and Dot Compliance offer trials after a request form or a call. The full list is below.

Open-source QMS software

We searched GitHub and the web for open-source QMS software that a device company could host itself.⁹ 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,¹⁰ with training records, versioned documents approved by entering credentials, and change and deviation events.¹¹ The vendor says it is “designed and built to meet biopharmaceutical quality standards like GXP, Part 11, Annex 11”.¹² 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.¹⁰¹²
• Odoo is open source in its Community edition, but its Quality, Documents and Sign apps are Enterprise-only.¹³
• 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.¹⁴ They are written for generic management systems in the ISO 9001 style; we found no ISO 13485 content in the repository.¹⁴
• 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.¹⁵
• 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”.¹⁶

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.

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,³ and you can download them without an account or an email address (October 2026).¹⁷ 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.”¹⁸ 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 2025.¹⁹ OpenRegulatory also makes Formwork, and its template pages promote it.²⁰

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.²¹ Document control runs on GitHub issues, pull requests with reviewers, and releases.²² 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,²¹²² 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.²³ It says it “is not, by itself, an adopting company’s operational QMS”,²⁴ and its maintainers sell help with tailoring and IQ/OQ/PQ validation.²⁴ 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.²⁵ 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.²⁶ 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.²⁷

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.²⁸ 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.²⁹ 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.³⁰ Part 11 applies to records in electronic form kept under any FDA records requirement.³¹ 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)).³¹ A shared drive or a plain Git repository doesn’t do this out of the box. See our 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.³² 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,¹ Cognidox from $8,000 a year and Greenlight Guru from $12,000 a year; see our QMS pricing overview 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 explains how we score trials.