The real cost of a QMS (and why most small companies can't afford it)

If you've ever been through the process of evaluating a Quality Management System for a software or medical device company, you'll know the feeling. You book the demo. The sales rep is lovely. Then the proposal lands and you quietly close the tab.

Enterprise QMS platforms are priced for enterprise companies. The problem is that most of the teams who genuinely need a QMS -- early-stage medtech startups, SaaS companies entering regulated markets, small software shops building CE-marked or FDA-registered products -- are not enterprise companies.

What enterprise QMS platforms actually cost

Let's be specific. The numbers below are based on publicly available information and conversations with teams who have been through these processes.

Onboarding and implementation fees typically run between €15,000 and €60,000 for platforms like Greenlight Guru, Veeva, and Qualio. This covers "configuration", training, and getting your existing documentation imported into their system. For a team of 5 engineers, this alone can exceed six months of runway.

Per-seat licensing commonly starts at €300 to €500 per user per month at the low end. A team of 10 people is looking at €36,000 to €60,000 per year before anyone has logged a single requirement.

Consulting fees are almost always required. Most platforms are complex enough that you'll need either their professional services team or an external QA consultant to help you set things up correctly. Expect to pay a consultant anywhere from €800 to €2,000 per day, and expect the engagement to last weeks.

Developer time is the hidden cost nobody talks about. And it is bigger than most founders realise. Every time a developer needs to update a requirement, log a verification, prepare a release, or run through a risk assessment, that is time pulled away from building the actual product. On a clunky platform with a steep learning curve, what should take 10 minutes takes an hour. A release that should be a structured 20-minute process becomes a half-day effort of manually cross-referencing records, chasing approvals, and hoping nothing was missed. Across a team of four engineers, the ongoing compliance overhead on a traditional QMS platform can easily consume two to three days of engineering time per month -- every month.

Disruption to workflow is also real. Swapping out the way your team tracks requirements, tests features, and approves releases mid-development is painful. Teams often find themselves maintaining both the old way and the new system in parallel for months, with motivation dropping every time the platform crashes or errors mid-task.

What you actually need

Here's the honest version: a QMS for a software or medtech startup is not that complicated in principle. You need to know what your product is supposed to do (requirements), prove it does those things (verifications), track how you tested it (test records), manage changes in a controlled way (change control), and have a process for dealing with problems when they arise (non-conformances, CAPAs).

That's it. The complexity in enterprise platforms comes from decades of features added for pharma companies with hundreds of products, global regulatory submissions, and dedicated QA departments with 20 people.

You don't need any of that.

What QualiHQ costs

QualiHQ is €49 per month for growing teams, flat rate, during our early adopter period. That is a fraction of what Greenlight Guru, Qualio, or Veeva charge -- and unlike those platforms, there is no onboarding fee, no implementation engagement, and no consultant required.

Where the saving is most significant is developer time. QualiHQ's AI bootstrap generates your initial QMS structure from a description of your product in under a minute. Requirements, verifications, and a risk analysis are created automatically and linked to your codebase. Test results flow in directly from your CI pipeline. Releases guide your team through the approval checklist and warn you if anything is missing before you proceed.

Tasks that used to take a developer half a day take minutes. A release that previously meant a manual afternoon of cross-referencing records is now a guided, automated process. For a team of four, that easily recovers two to three days of engineering time per month -- time that goes back into building the product.

The platforms that came before QualiHQ were built for enterprises and priced accordingly. We built QualiHQ for the teams that actually need a QMS but can't justify the cost or the disruption of the traditional options. Compliant, automated, and priced like a SaaS tool rather than a consultancy engagement.

For the full story on why this problem exists and what we set out to fix, read the founder note.

Want to see it in action? Start your free trial -- no credit card required for the free plan.