Overview
qointa helps global sponsors, CROs, and MedTech innovators validate, deploy, and govern wearables, software as a medical device, and point-of-care devices in clinical trials compliantly and inspection-ready. The company serves 8 of the top 20 pharmaceutical clients and enables 50% faster digital health technology deployment.
Key people
In the news
- The first four modules — Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance — are now mandatory across the EU. And one group keeps getting caught out: importers who didn’t realise they were importers. If a non-EU device (yes, often straight from China) is placed on the EU market by an EU-established company, that company is an importer under MDR Article 13 — with duties that don’t wait for the manufacturer. Our new field-notes piece walks through what we keep finding on real
- We just published a new article, and we're going to be honest — the title was something we've all said in a feasibility meeting. "It's just a phone." Turns out, that four-word sentence can open four separate regulatory regimes simultaneously — and most study teams plan for zero of them. In this piece we walk through five myths about study-phase smartphones, why a one-time Regulatory Impact Assessment isn't enough, and the one question every inspector eventually asks. If you work in clinical digital health, DHT governance, or QARA —
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