We built the framework because we kept being asked the same question late
Sponsors did not come to us asking for a governance model. They came late, with a device already chosen, a protocol already written, and a question that should have been answered months earlier: is this thing regulated, and what does that mean for us?
Answering it once is consulting. Answering it the same way every time, so the reasoning holds when a different person asks two years later, is a framework. That is what qointa became.
Quality is in the name, not the marketing
qointa stands for Quality Observations In Treatment Assets. It describes the work literally: the observations a treatment asset produces are only worth what the quality system around them can demonstrate. A measurement no one can defend is not evidence.
We have sat on both sides of the table
Our people have run trials inside sponsors and delivered technology into them as vendors. We have written the requirements and we have been audited against them. That matters more than it sounds: most compliance advice fails not because it is wrong, but because it is unimplementable by the team that has to live with it.
It is also why we do not sell a deck. An engagement produces controlled artefacts you keep — a recorded decision per perimeter, the reasoning behind it, and the register of what would change the answer.
We publish our reasoning
The framework is documented rather than asserted. The position papers and whitepapers in our library set out how we qualify a device, how we classify a mid-study change, and where the frameworks contradict each other at the edges. You can read the method and judge it before you engage us — which is the point.
What we are not
We are not a generalist quality consultancy that also does digital, and we are not a staffing firm. We work on digital health technologies in regulated research, and when a request sits outside that, we say so and point elsewhere. A specialist who takes everything is not a specialist.
