Greenlight Guru vs QualiHQ: medical device QMS for software teams

Greenlight Guru comes up a lot in medtech conversations, and for good reason. It is one of the few QMS platforms that was built specifically for medical devices rather than adapted from a general quality management tool. If you are looking at QMS options for a regulated software product, you have probably already found it.

Here is an honest look at how it compares to QualiHQ, and who each one is actually for.

What Greenlight Guru is

Greenlight Guru is a medical device quality management platform that covers the full product lifecycle: design controls, risk management, document control, CAPA, supplier management, post-market surveillance, and audit readiness. It aligns closely with FDA 21 CFR Part 820 and ISO 13485 and is built around the assumption that your team includes people whose job is quality.

It is genuinely well-regarded in the medical device space. The UDI management, design history file structure, and MDR-specific workflows are better than most competitors. If you are building a hardware medical device or a combination product, it handles things that software-focused tools do not.

The gap for software teams

The challenge for pure software teams -- SaMD, digital health, medical device software -- is that Greenlight Guru is built around the hardware product lifecycle. Design controls map well to a physical device with mechanical drawings and component specifications. They map less naturally to a software codebase with requirements, test cases, and CI pipelines.

There is no concept of importing your test results from JUnit or pytest and linking them to verification records automatically. There is no AI that reads your README and generates your initial requirements. The traceability between your development process and your quality records has to be maintained manually, which is fine when you have a quality manager doing it, but creates real overhead for a dev team doing it themselves.

Greenlight Guru also assumes you know what you are doing from the start. The onboarding is comprehensive, but there is a learning curve, and you are expected to arrive with a working understanding of design controls and document control processes. For a software developer who is responsible for compliance alongside actually building the product, that curve adds up.

Pricing

Greenlight Guru does not publish pricing. Based on publicly available information and user reports, entry-level plans typically start around $1,000-1,200 per month with annual commitments. It is not uncommon for total cost to run significantly higher depending on module selection and team size.

QualiHQ is free to start. Paid plans are a fraction of Greenlight Guru's entry price, and the AI generation that produces your initial requirements, verifications, and traceability structure is included from day one.

Who should use Greenlight Guru

• Medical device companies building hardware or combination products where design history file structure and UDI management matter
• Organisations with a dedicated quality team that will own and operate the platform
• Teams preparing for FDA 510(k) submissions or MDR notified body assessments where a comprehensive, auditor-familiar platform is a genuine advantage
• Companies with a compliance budget that reflects the size of what they are building

Who should use QualiHQ

• Software teams building SaMD, digital health tools, or medical device software where developers are responsible for compliance
• Startups who need to get from zero to audit-ready without hiring a quality manager first
• Teams who want AI to generate requirements, verifications, and traceability from their existing documentation and test results
• Dev teams who want compliance to be part of their normal release process rather than a separate effort that runs alongside it

The honest summary

Greenlight Guru is an excellent platform for the medical device company it was designed for. That company has a quality manager, a regulatory affairs team, and a budget that reflects the seriousness of what they are building.

If that is not you yet -- if you are a software team figuring out IEC 62304 compliance for the first time, preparing for your first enterprise sales call, or trying to get your QMS in order before a notified body submission -- Greenlight Guru is going to feel like a lot of platform and a lot of cost for where you are right now.

Start with what fits. You can always move to a more comprehensive platform when your quality function is mature enough to warrant one.

Start free on QualiHQ -- no card required. Generate your first requirements structure from your README in about 30 seconds.