Global Regulatory enablement for Digital Health Technologies
Partner with qointa for Confidence in Compliance
With Device360™, you’re not just buying a service — you’re gaining a global compliance partner. We help you reduce risk, accelerate timelines, and protect the integrity of your trial data.
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Classify, document, and justify your device use — anywhere in the world.
DeviceReg guides sponsors through global classification, regulatory justification, and submission-ready documentation for Digital Health Technologies in decentralized and hybrid trials.
Why it matters:
Incorrect classification or missing documentation can result in IRB rejection, regulatory delays, or customs holds. DeviceReg eliminates these risks with precise, jurisdiction-specific enablement.
Our services include:
Device classification mapping (FDA, EU MDR 2017/745, PMDA, NMPA, UK MDR, Health Canada)
ISO 14971:2019-compliant risk assessments
Regulatory Impact Assessments for device, software, or geography changes
Importer/Distributor/System Producer role mapping per EU MDR Articles 13–16, 22
Submission-ready documentation: CE, 510(k), UDI, DoC, IFU
IRB/ethics approval support
Compliance built in:
Aligned with ISO 13485, FDA 21 CFR, EU MDR, IVDR, PMDA, NMPA, UK MDR, and Health Canada requirements.