Get your device trial-ready — in one engagement.

For MedTech founders, regulatory affairs leads, and product teams moving a commercial device into clinical research. Classification, validation, and multi-jurisdiction registration, handled as one coordinated workstream.

Your device works. Users love it. Post-market data is strong. Then a sponsor or CRO asks you to support a clinical trial — and suddenly you need a trial-specific regulatory package, a clinical-grade validation story, site training materials across multiple countries, and answers to EU MDR, FDA 812, ISO 14971, and IEC 62304 questions all at once. A commercial device is not the same thing as a clinical-trial device. We bridge the gap.

WHAT WE HANDLE

1. Commercial-to-Clinical Bridge

Gap analysis between your current regulatory file and what clinical research requires — jurisdiction by jurisdiction.

2. Trial-Grade Validation

Usability, performance, and safety validation for clinical populations (IEC 62366-1, ICH E6(R3)) — with real-world evidence strengthening the package.

3. Multi-Jurisdiction Registration

Investigational Device Exemption (IDE / FDA 812), EU MDR Article 62, country-specific approvals, and the reconciliation strategy to keep them aligned.

4. Sponsor & CRO Readiness

Documentation, labelling, training materials, and audit responses — packaged the way sponsors and CROs need to receive them.

HOW WE WORK WITH MEDTECH

1. Readiness assessment — Where you are vs. where a sponsor will need you to be, with a prioritised gap list.

2. Engagement — Fixed-scope delivery of the missing pieces, without disrupting your commercial product team.

3. Sustained support — Ongoing partnership as your device enters more trials, more jurisdictions, and more indications.

WHY MEDTECH CHOOSE QOINTA

• Device-fluent, trial-fluent. We speak both MedTech and clinical research — rare in one partner.

• Founder-compatible. We structure engagements for small teams, not just large MedTechs.

• No surprises at the regulator. We build the submission the reviewer expects, not the one we wish they'd accept.

• Sponsor-ready outputs. Our deliverables are already formatted the way sponsors and CROs want to receive them.