Seamless, Compliant Integration for POC 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.
Turn device data into reliable, regulatory-grade evidence.
DeviceConnect ensures your Point-of-Care (POC) devices integrate seamlessly with eCOA, EDC, eSource, and SaMD platforms, enabling real-time, traceable, and audit-ready data flows across decentralized and hybrid trials.
Why it matters:
Integration errors, missing timestamps, or untraceable metadata can invalidate trial endpoints, delay submissions, and trigger audit findings. DeviceConnect mitigates these risks with globally compliant integration processes.
Our services include:
System Integration Architecture Design – Future-proof connectivity across trial systems.
Metadata Tagging & Timestamp Synchronization – Ensure data provenance and traceability.
SaMD/API Validation – Fully aligned with 21 CFR Part 11 and ISO 27001 security standards.
AI/ML Compliance Consulting – Support for EU AI Act and FDA Predetermined Change Control Plans (PCCP).
Compliance built in:
Aligned with ISO 13485, FDA 21 CFR, EU MDR, PMDA, NMPA, and Health Canada requirements for device data integrity and security.