Find out which perimeters your device already crosses.
The DHT Readiness Scorecard. Sixteen questions, about ten minutes, an immediate score per perimeter and the gap that decides it — for devices a trial relies on, whether or not the device is itself under investigation. Nothing to sign up for.
Scored against EU MDR, FDA digital health and DCT guidance, the ISO and IEC standards, and GxP expectations. Most people taking it are sponsors or CROs. Manufacturers and supply-chain partners get questions of their own.
Investigator site? Read the Stakeholder Edition for CROs and sites instead.
A high-level readiness snapshot. Regulatory status, IDE requirements and risk classification must be determined for each specific technology, indication and study design; this scorecard shows whether the processes and documentation are in place. The scoring model, category weightings and remediation logic are proprietary to qointa. It is not legal, regulatory or professional advice, and it is not an approval, a clearance or a certification.
What this costs you if it stays as it is
A perimeter crossed unnoticed is found at inspection, where it is expensive. We assess the position, record the reasoning, and hand back a register that survives staff turnover and stands up to challenge.
See what an engagement covers