Best QMS for Class II medical devices in 2026

Class II is where most Software as a Medical Device lands. In the US, that means a 510(k) pathway -- demonstrating substantial equivalence to a predicate device. In Europe, Class IIa and IIb require a notified body conformity assessment. In both cases, your QMS is a central part of what gets reviewed.

Here is what QMS software works best for Class II medical device teams.

What Class II compliance requires

Class II medical devices must demonstrate that they are substantially equivalent (US) or conformant with the General Safety and Performance Requirements (EU MDR) -- and that the organisation that built them has a quality management system in place that can be held accountable for that claim.

For a software Class II device, the QMS evidence includes:

• Software requirements specification with documented approval
• Verification and validation records showing requirements were tested and passed
• Traceability matrix linking requirements to verification to test evidence
• Risk analysis under ISO 14971
• Design history file (US) / technical documentation (EU)
• CAPA records for any non-conformances identified during development
• Post-market surveillance plan

The FDA and EU notified bodies both review this documentation. For software devices, reviewers are increasingly sophisticated about what well-maintained records look like versus documentation assembled under pressure just before submission.

The options

| Tool | 510(k) / Class IIa support | Software-focused | Free tier | Starting price | |---|---|---|---|---| | QualiHQ | Yes | Yes | Yes | Free | | Greenlight Guru | Strong | Partial | No | ~$1,000+/month | | Qualio | Yes | Partial | No | ~$500-800+/month | | MasterControl | Yes | No | No | Enterprise |

QualiHQ

Generates your requirements, verifications, and traceability automatically from your product documentation. Release management enforces approval before publishing. Risk analysis, CAPA, and document control included. The audit trail QualiHQ produces maps to what 510(k) reviewers and notified bodies expect to see. Free to start.

Best for: Class II SaMD startups where developers are managing compliance.

Greenlight Guru

Strong 510(k) and EU MDR alignment. Used by many teams that have successfully completed Class II submissions. Hardware orientation is a weakness for pure software products. Pricing reflects the enterprise medical device market.

Best for: Class II medical device hardware companies with a quality team.

Qualio

Broadly compliant with ISO 13485 and FDA quality system requirements. Strong document control. Designed for quality professional users.

Best for: Class II teams with a dedicated quality manager.

The recommendation

If you are building Class II SaMD, the most important thing you can do is get your records in order well before you need to submit or face an audit. The teams that struggle with Class II submissions are the ones who tried to reconstruct documentation that should have been maintained continuously.

Start with a tool that builds the record automatically as you develop, approve, and release.

QualiHQ is free to start. Build your Class II QMS as you build your product. No credit card.