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.
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In the news
- Our new home is live. https://qointa.com Same mission: make every DHT in your trial defensible — to regulators, inspectors and patients. Meet me at SCOPE Europe, Barcelona, 12–14 October. #DigitalHealth #ClinicalTrials #DHT #MDR #SCOPEEurope
- In 2007 we built one of the first integrated eClinical platforms. EDC, eCOA, RTSM and compliance on one database. Nearly twenty years later the hard problem in clinical trials isn't the data platform. It's the device(s) in the patients hand. A smartwatch, a sensor patch, a study phone. Every one of them raises questions most protocols never answer: → Is it a medical device in this trial — and who is the manufacturer? → Who imported it, and are they registered? → What happens to your endpoint when the firmware updates mid-study? → Can
- 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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