DHT QMS: The Missing Link Between Mature Systems and Digital Health Readiness
Introduction
Most life science organizations—sponsors, CROs, technology vendors, and service providers—already operate under robust Quality Management Systems. They have CAPA, change control, SOPs, and training modules down to an art form. But as digital health technologies (DHTs) become core to endpoint data collection, traditional QMS frameworks are being tested—and found incomplete.
Why? Because DHTs sit at the intersection of medical device regulation, clinical trial governance, and software lifecycle management. Most existing QMSs cover one or two of those dimensions—but not all three. Without adaptation, even the most mature quality systems fail to produce what regulators and sponsors now demand: clinical-grade digital evidence.
The New Definition of Quality
Under FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745, device manufacturers must demonstrate full lifecycle control over design, validation, and performance. Yet when DHTs are used in trials, these expectations apply equally to sponsors, CROs, and vendors who collect or process regulated data. The FDA’s 2023 DHT Guidance clarified that sponsors remain responsible for device validation and data integrity, regardless of outsourcing.
The issue isn’t the absence of quality—it’s the absence of the right kind of quality system.
Where Current QMS Frameworks Fall Short
| Existing QMS Strength | Digital Health Gap |
|---|---|
| GCP & Part 11 compliance | No alignment with ISO 13485 design control |
| Vendor management | No audit criteria for app developers or cloud AI vendors |
| Data integrity | Missing traceability between sensor data and clinical endpoints |
| CAPA effectiveness | No linkage between algorithm updates and clinical risk |
In short, most QMS architectures manage process quality—not product-device quality.
Real-World Impact
A global CRO recently discovered this gap the hard way: its validated EDC and eCOA systems passed inspection, but the wearable sensor data feeding them did not. Why? Because the devices lacked documented risk control and usability validation under ISO 14971 and IEC 62366.
The CRO’s QMS was compliant—but not DHT-competent.
The DHT-Adapted Quality Framework
To modernize existing QMS infrastructures, sponsors and vendors must integrate device-level governance within existing GCP structures.
Key additions include:
Design and Development Files – Capture DHT configuration, risk class, and validation evidence.
DHT Supplier Qualification – Extend vendor assessments to include ISO 13485/14971 compliance.
Algorithm and Firmware Change Control – Track all updates that could alter data output.
Traceability Matrices – Map DHT data flows from sensor to statistical endpoint.
Real-World Performance Monitoring – Post-deployment checks for accuracy and usability in participant settings.
These additions don’t replace your QMS—they elevate it.
Building Clinical-Grade Confidence
Regulators, partners, and investors now view quality maturity as digital maturity. A QMS that integrates DHT oversight signals reliability, transparency, and inspection readiness. Organizations that upgrade their systems now will gain not just compliance—but market trust. In the hybrid future of trials, your QMS is no longer an internal tool—it’s your license to operate.
References
FDA. Quality system regulation (QSR). 21 CFR Part 820. 2023.
ISO 13485:2016. Medical devices – Quality management systems. Geneva: ISO; 2016.
European Commission. Regulation (EU) 2017/745 on medical devices (MDR). Brussels: EC; 2017.
FDA. Digital health technologies for remote data acquisition in clinical investigations. Guidance. 2023 .
EFPIA. Reflection paper on integrating medical devices into medicinal product clinical trials. Brussels: EFPIA; 2025 .
