Greenlight Guru pricing, what startups actually pay in 2026
By QualiHQ Team
Greenlight Guru is probably the best-known QMS platform built specifically for medical devices. It is also one of the least transparent on price. There is no public rate card and no self-serve signup; the path to a number runs through a sales process, and the number that comes out is negotiated per deal.
If you are an early-stage team trying to budget, that is a problem. Here is what can be said from publicly reported figures.
What buyers report
Contracts commonly run one to two years, paid annually up front. Evaluation is demo-led; there is no free trial. For a pre-revenue startup, the initial commitment is therefore substantial before your team has lived in the product for a week.
Reported pricing for smaller companies clusters in the €20,000 to €50,000 per year range, with the lower end reflecting minimal seats on the core document and quality modules, and the upper end reflecting design controls, risk, and their clinical offerings. Larger or multi-product deployments are reported well above that. As with any sales-priced product, treat these as buyer-reported ranges, not a quote.
Implementation and training may be quoted separately, and reported onboarding engagements range from included-in-contract to five-figure add-ons depending on migration scope.
To be fair to them: Greenlight Guru's medical device focus is real. Their tooling maps to design controls and risk management the way a generalist document platform does not, and for a funded scale-up with a quality team, the platform earns its place on shortlists.
The startup maths problem
The issue is not whether the platform is good. It is proportionality. A typical seed-stage SaMD team is three to eight people, pre-CE-mark, with a runway measured in months. €20,000 to €50,000 a year for compliance software, before consultant fees and before certification costs, is a meaningful percentage of that runway spent on infrastructure for a product that cannot legally be sold yet.
The counterargument you will hear is that the cost of getting compliance wrong is higher. That is true. But the conclusion does not follow, because the choice is not between an enterprise platform and getting it wrong. The standard is the same regardless of the software that holds your documents. What you need is a system your team uses, with traceable evidence. What that costs is a separate question from what any one vendor charges.
Questions worth asking on the demo
Get the total first-year cost in writing, including implementation and training. Ask the contract length and what early termination looks like. Ask what your data export looks like if you leave, in what format, and whether it preserves your audit trail. Ask which modules your quote includes, since design controls and risk are the heart of a device QMS and should not be surprises. And ask what the renewal uplift has looked like for comparable customers.
Where we stand, stated plainly
We build QualiHQ, a lean, lightweight QMS for exactly the teams priced out of the conversation above. Our pricing lives in exactly one place, the pricing page, and there is a free trial. If a walkthrough would help, book a demo, we enjoy giving them.
If you are evaluating, our Greenlight Guru alternatives comparison does the feature-by-feature work, and what ISO 13485 actually costs a startup puts platform pricing in the context of your whole compliance budget.
And if you have not yet confirmed what class of device you are building, start there, because it decides everything downstream: our classifier takes five minutes and gives you the likely EU MDR class, the IEC 62304 class, and the path between you and market.
Not sure where you stand? Find out in two minutes.