About · Threeqa

Why we exist

The QMS isn't the work. It's what's keeping you from it.

Walk into any medical-device company and the same artefacts are scattered across the same five tools: SOPs in SharePoint, requirements in Jira, risks in a 200-row Excel file, design outputs in Confluence, sign-offs in DocuSign. The work the QMS demands - that everything links to everything, that every change is traceable, that nothing has fallen out of sync - is somebody's full-time job, every quarter, forever.

We've been on both sides of that table. Threeqa exists because we got tired of writing the same trace matrices, the same risk files, the same audit trail by hand - and we knew exactly which clauses we were satisfying when we did. The platform encodes those clauses so the team can spend its time on the device.

We don't replace your notified body or your FDA contact. We make sure the artefacts you hand them are complete and traceable.

Marcos & the Threeqa team

Co-founder, Threeqa · hello@threeqa.com

Where we are

Engineered in Ljubljana, built for EU and US medtech.

Threeqa is engineered in Ljubljana, Slovenia - in the same regulatory neighbourhood as the notified bodies, MDR competent authorities and quality auditors our customers work with every day. Our cofounders have shipped medical device projects across the EU and US, so the platform reflects real audit and inspection experience on both sides of the Atlantic. We support customers across the EU/EEA and in the United States preparing for the QMSR transition.

If your QMS already runs against ISO 13485:2016, EN ISO 14971:2019/A11:2021 and IEC 62304, the platform plugs into the artefacts you already have. If you're starting from scratch, the standards-aligned templates are the starting point, not a 200-page Word document you'd have to rewrite.

What we believe

Three principles the platform encodes.

Standards are not paperwork.

IEC 62304, ISO 14971, ISO 13485 and 21 CFR Part 820 exist because they describe how good engineering for safety-critical systems actually works. We treat them as the design brief, not as compliance theatre.

Traceability has to be by construction.

A trace matrix that someone has to remember to update is a matrix that's already wrong. Threeqa builds links as a side-effect of the work itself, so the file is always the source of truth - never the spreadsheet a person reconciled at 11pm.

A conformity assessment should be a confirmation, not a discovery.

By the time someone from a notified body or the FDA opens your file, the answers to their questions should already be in it. Our job is to make sure the artefacts they hand you a finding on don't exist.

Built by people who've shipped complex medical device programs.