Validation & Risk Assurance for Trial Devices
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.
Only deploy devices proven to meet your trial’s technical, clinical, and regulatory needs.
DeviceFit ensures every POC device is fit-for-purpose, compliant, and safe for use with your study population before deployment.
Why it matters:
Unvalidated or misaligned devices can compromise endpoints, create safety risks, and trigger post-market corrective actions.
Our services include:
Human factors & usability testing (EN 62366-1)
Device-specific risk analysis (ISO 14971)
Clinical accuracy & endpoint alignment verification
Regulatory equivalence for consumer vs. medical-grade devices
SaMD classification & cybersecurity review (ISO/IEC 62304, MDR Rule 11)
Compliance built in:
Meets global standards for device validation, including ISO 13485, ISO 14971, and applicable regional regulations.