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This assessment provides an initial evaluation of your organization’s readiness to deploy Digital Health Technologies (DHTs) in clinical trials and real-world evidence (RWE) initiatives. These DHTs are not part of the clinical investigation but are used to support data capture, monitoring, and endpoint generation.

Regulatory status, IDE requirements, and risk classification must be determined for each specific DHT, indication, and study design; this assessment only highlights whether key processes and documentation are in place.

Note: This assessment offers a high-level compliance snapshot. Full scoring methodology, risk models, and remediation workflows are proprietary to qointa Device360™. For regulatory-grade evaluations, professional consultation is recommended. This tool does not constitute legal, regulatory, or professional advice, nor does it represent any regulatory approval or certification.

Select your stakeholder type to begin an assessment aligned with EU MDR, FDA Digital Health & DCT guidance, ISO/IEC standards, and global GxP expectations.