Best QMS for software-only medical devices in 2026

Software-only medical devices -- SaMD with no hardware component -- are in an interesting position in the QMS market. The regulatory requirements are real (IEC 62304, ISO 13485, ISO 14971, MDR/FDA), but the workflows these regulations describe were written with hardware products in mind.

Design controls assume something to design. Manufacturing controls assume something to manufacture. Supplier quality assumes physical component suppliers. For a team building a web application or a mobile app that happens to be a medical device, a lot of the traditional QMS tooling is solving problems you do not have.

What a software-only medical device team actually needs

Strip away the hardware-specific concepts and the core QMS for a software medical device is:

• Software requirements that describe what the product is supposed to do
• Verifications that describe how each requirement will be tested
• Test execution records (your test runs) that prove the verifications passed
• A traceability matrix linking all three
• A risk analysis identifying what could go wrong with the software and what controls are in place
• A structured release process: who approved the release, when, with what evidence
• Non-conformance (bug) management and CAPA for significant issues
• Standard operating procedures for development, release, and quality processes

That is a meaningful amount of documentation. But it is substantially less than a QMS designed for a medical device with physical components, suppliers, manufacturing processes, post-market field safety, and product registration across hardware and software components.

The options

| Tool | Software-specific features | Hardware assumptions | Free tier | |---|---|---|---| | QualiHQ | Yes -- built for software teams | None | Yes | | Qualio | Partial | Minimal | No | | Greenlight Guru | Partial | Significant | No | | Arena QMS | Partial | Heavy (PLM integration) | No | | MasterControl | Partial | Significant | No |

QualiHQ

The only tool in the mainstream QMS market specifically designed for software development teams. No hardware assumptions -- the concepts, workflows, and data model are built around requirements, verifications, test runs, and software releases.

AI generates your initial requirements and verifications from your existing documentation (README, design doc). JUnit and pytest XML test results import directly. Traceability is built automatically. Releases require verified test evidence before approval. Free to start.

Best for: Software-only medical device teams managing their own compliance.

Qualio

Life sciences QMS with minimal hardware-specific assumptions. Document control, CAPA, and training management work for software teams. No native software development integration -- no test result imports, no auto-generated traceability. Better fit for software teams than the hardware-centric platforms.

Best for: Software medical device companies with a dedicated quality manager.

Greenlight Guru

Built around the medical device product lifecycle, which includes significant hardware assumptions. Design history file structure, UDI management, and component-level traceability are strong features for hardware devices that are irrelevant overhead for software-only products. Better than general enterprise QMS for medical device compliance generally, but the hardware orientation creates friction for pure software teams.

Best for: Combination products or hardware medical devices.

The recommendation

If you are building a software-only medical device, the best tool is one that was built for that specific context. Hardware-centric tools make you model a product structure you do not have and navigate workflows built for physical components. Start with something that speaks the language of software development.

QualiHQ is free to start. Built for software-only medical devices. No credit card required.