Run DHT-enabled trials without the compliance drag

For VPs of Clinical Operations, Heads of Regulatory, and Chief Medical Officers balancing aggressive protocol timelines against multi-framework compliance. We take the digital health technology problem off your plate — from classification through inspection.

Adding a wearable, a point-of-care device, or medical software to your protocol triggers obligations under EU MDR, FDA 21 CFR, ISO 14971, IEC 62304, GDPR, and increasingly the EU AI Act — multiplied across every country your trial touches. Most sponsor RA teams were built for drug submissions, not device compliance. The result: classification debates that delay protocol sign-off, validation plans that don't survive review, and inspection exposure nobody wants to discover at first audit.

WHAT WE HANDLE

1. Protocol-Ready Classification

Jurisdiction-by-jurisdiction regulatory status for every DHT in your protocol — so IRB submissions and sponsor governance meetings stop stalling on device questions.

2. Endpoint Defensibility

Validation of device-generated endpoints that holds up in regulatory submission and against competitor challenges — ISO 14971, IEC 62366-1, and real-world evidence built in.

3. Global Trial Enablement

Labelling, customs, site training, and cross-border data flow strategy for multi-country trials. One partner, every jurisdiction.

4. Inspection Readiness

Audit-ready files, inspection response playbooks, and AI/ML change control documentation (FDA PCCP, EU AI Act) — so pre-inspection reviews go from stressful to routine.

HOW WE WORK WITH SPONSORS

A short three-step strip — gives sponsors confidence you have a methodology, not just capability.

1. Scoping — A 15-minute call followed by a written readiness assessment specific to your protocol and jurisdictions.

2. Engagement — Fixed-scope deliverables with clear milestones, integrated with your existing CRO and RA workflows.

3. Handover — Audit-ready files, trained internal teams, and ongoing oversight options for the trial lifecycle.

WHY SPONSORS CHOOSE QOINTA

• Specialist, not generalist. Digital health technologies in regulated research is our entire business.

• Sponsor-side fluency. We speak VP Clinical Ops, Head of Regulatory, and CMO — not just regulator.

• Inspection-ready by design. Every deliverable built to survive FDA, EMA, and notified body scrutiny.

• CRO-compatible. We work alongside your existing CRO without turf wars or duplication.