A note from the founder: why I built QualiHQ

A few years ago I was CTO of an AI company building software for people with diabetes. Technically, we were in good shape. The product worked. The team was strong. But as we moved towards a regulated market, we needed a Quality Management System in place.

What followed was one of the most frustrating experiences of my career -- and not for the reasons you might expect.

The options were all terrible

I spent a lot of time evaluating QMS platforms. Every one of them was confusing. The documentation was dense, the feature sets were overwhelming, and it was genuinely hard to understand what you actually needed versus what was there because a pharmaceutical company with 500 employees had asked for it at some point.

We were based in a shared building with other startups at the time. A few of them had been through the same process and pointed us towards the platform they were using. Their honest feedback: it was crazy expensive, the learning curve was brutal, and one of the founders had been on a free trial extension for so long he'd basically given up trying to get procurement approval for the real thing.

We went with it anyway because it was the cheapest of the options we'd found. It still cost around $10,000.

The UI made everything harder

The platform itself was clunky and unreliable. It errored regularly. Things that should have taken minutes took much longer because you'd hit a bug halfway through and have to start again. Getting developers to use it consistently was a constant battle -- not because the team didn't care about compliance, but because the tool was actively unpleasant to work with. Asking engineers to context-switch into a slow, confusing interface and break their normal workflow every time they touched a requirement or a test record was a tough sell. And when the tool errors on you twice in a row, you stop trying.

The GitHub Actions experiment

Eventually we built a workaround using GitHub Actions to push test results into the platform automatically. It helped, but it only solved one small part of the problem.

Releases were still a nightmare. There was no way to automatically link test results to a specific release. Every release became a manual effort -- going through requirements one by one, updating verification records, checking test runs, trying to remember whether the risk assessment had been reviewed, realising it hadn't, reopening it, going back to link affected items we'd missed. No warnings if a requirement had no linked verification. No prompt if a risk item hadn't been reviewed. Just you, trying to hold the entire thing in your head and hoping you hadn't missed anything before you hit approve.

We missed things. Everyone does, in that kind of system.

Why that bothered me more than it should have

In a different industry, a clunky internal tool is just an annoyance. In medtech, the QMS is directly connected to patient safety. A missed risk item or an unlinked requirement isn't just a process failure -- it's a gap in your evidence that what you shipped is safe.

The tools available to small companies in this space should make it easier to do this properly, not harder. Instead we had a system that actively made compliance feel like an obstacle rather than a practice.

What QualiHQ is

QualiHQ is built around the problems I actually had. Requirements are linked automatically to your codebase. Verifications are connected to requirements, and you get a warning if something is missing. Test results flow in directly. A release won't let you proceed if your risk assessment hasn't been reviewed or if there are unlinked items. The whole audit trail builds itself as you work.

The onboarding takes minutes, not months. The interface is built for developers, not for QA departments in pharma companies. And the pricing is a fraction of what we paid for a platform that made our lives harder.

Our mission is simple: help small companies stay compliant, build better processes, and ship safer products without it costing them their runway or their sanity. Compliance should make your product better. It shouldn't make your team miserable.

I hope QualiHQ is the tool I wish we'd had.

-- Keith

If you want the numbers behind what enterprise QMS platforms actually charge, we broke that down in detail here.

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