Best QMS software for FDA submission in 2026

If you are preparing for an FDA submission -- 510(k), De Novo, or PMA -- your Quality Management System is not just something you need to have in place. It is something an FDA reviewer will examine and, depending on your device class, something that may be subject to inspection.

This post covers what your QMS needs to support for FDA submission, and which tools are best suited to that.

What FDA expects from your QMS

For most software medical device companies, FDA compliance centres on 21 CFR Part 820 (Quality System Regulation) and, increasingly, the FDA's alignment with ISO 13485. For software specifically, the FDA expects:

• A documented software development lifecycle that aligns with IEC 62304
• Requirements traceability -- requirements documented, linked to how they were tested, with test evidence attached
• A structured release process with documented approval
• Design history file contents (requirements, design, testing, risk analysis)
• A CAPA process for non-conformances
• Post-market surveillance procedures

The technical documentation you submit for a 510(k) or De Novo will reference your quality system. If the FDA inspects your facility (more likely for higher-risk devices or if they identify concerns), they will want to see your QMS in operation.

What this means practically

Your QMS software needs to produce evidence that meets FDA expectations -- not just records that look like evidence. Specifically:

• Requirements must be versioned and approved, not just written down
• Test evidence must be attached to the verifications it covers, not stored separately
• Release records must show who approved what and when, with an audit trail
• Non-conformances must be formally logged, investigated, and closed

The options

| Tool | FDA-aligned | Software-focused | Free tier | Starting price | |---|---|---|---|---| | QualiHQ | Yes | Yes | Yes | Free | | Greenlight Guru | Yes | Partial | No | ~$1,000+/month | | Qualio | Yes | Partial | No | ~$500-800+/month | | MasterControl | Yes | No | No | Enterprise | | Veeva Vault | Yes | No | No | Enterprise |

QualiHQ

Produces the records an FDA reviewer expects: versioned, approved requirements linked to verifications with test evidence attached. Structured release approval with audit trail. CAPA management. AI generation of initial QMS from your product documentation. Free to start.

The AI-generated requirements and verifications are a starting point for review -- you approve them, which creates the documented approval record the FDA expects.

Best for: SaMD and software medical device teams preparing for 510(k) or De Novo submission.

Greenlight Guru

Strong FDA 510(k) alignment. Design history file structure maps closely to 21 CFR Part 820. Used by many companies that have successfully navigated FDA submissions. Hardware orientation means stronger fit for combination products than pure software.

Best for: Medical device companies (especially hardware) with a quality team preparing for FDA submission.

Qualio

ISO 13485 aligned and broadly FDA compatible. Less specifically designed around 510(k) pathways than Greenlight Guru, but solid for the underlying quality management requirements.

Best for: Life sciences teams with a quality manager.

MasterControl and Veeva

Enterprise platforms with proven FDA submission track records. Cost and complexity appropriate for large regulated manufacturers preparing PMA or complex 510(k) submissions.

Best for: Large regulated manufacturers.

A note on FDA inspection

If your device is higher-risk or if the FDA has concerns following your submission, an inspection (QSIT audit) is possible. Having your records in a purpose-built QMS is significantly better preparation than having them in a Google Drive. The ability to pull up a specific release record, show the approval trail, and navigate to the supporting verifications in minutes is what a well-run QMS inspection looks like.

QualiHQ is free to start. Build the records your FDA submission will reference. No credit card required.