Best free ISO 13485 software in 2026

ISO 13485 sets out the requirements for a Quality Management System for medical device companies. Getting compliant does not require expensive software -- but it does require a real system. Here is an honest look at what free options exist and what they actually give you.

What ISO 13485 software needs to do

ISO 13485 covers your entire QMS: document control, design and development controls, production and service provision, non-conformance management, CAPA, and management review. For a software company, the most relevant requirements are:

• Controlled documents with version history and approval records
• Design and development: requirements, verification, validation, and change control
• Non-conforming product: formal bug and defect management
• CAPA: corrective and preventive action process for significant issues

"Free ISO 13485 software" needs to support all of these, not just document storage.

The options

QualiHQ (free tier)

The only free option that covers the full scope of ISO 13485 requirements for a software team. Document control with versioning and approval workflows. Requirements and verifications with approval records. Traceability. Release management with enforced sign-off. Issue management as non-conformance records. CAPA management. Risk analysis under ISO 14971.

AI generation included -- your initial requirements, verifications, and traceability structure generate from your product documentation in about 30 seconds. No manual blank-form filling to get started.

Free tier: one product, one AI generation. No time limit, no credit card.

Covers ISO 13485: Yes, for the clauses relevant to a software company.

Open-source QMS

Tools like OpenQMS exist. Free to use, require self-hosting. Setup and maintenance cost in engineering time. Validation overhead if you are in a GxP environment.

Covers ISO 13485: Depends on the tool and your configuration.

Qualio, Greenlight Guru (paid, no free tier)

Both are ISO 13485 aligned and well-regarded. Not free. Qualio and Greenlight Guru typically require a multi-year contract -- no self-serve trial. Enterprise pricing, starting around $500-1,000+ per month.

The honest comparison

| Tool | Covers ISO 13485 | Free tier | Enforcement | AI generation | |---|---|---|---|---| | QualiHQ | Yes | Yes, no time limit | Yes -- blocks non-compliant actions | Yes | | Open-source | Possible | Self-hosted | Depends | No | | Qualio | Yes | No | Yes | No | | Greenlight Guru | Yes | No | Yes | No |

The recommendation

If you need free ISO 13485 software that actually enforces the standard (not just stores records), QualiHQ's free tier is the only option that delivers that. Start with it, generate your initial QMS structure, and upgrade when the free tier limits become a real constraint.

QualiHQ is free to start. ISO 13485-aligned QMS with enforced workflows. No credit card, no time limit.