Medical Devices

Medical device clinical work sits at the intersection of ISO 14155 GCP expectations, design controls, and claims the device must support. Viltis helps manufacturers and clinical teams plan and run device studies that produce usable clinical evidence for 510(k), De Novo, PMA, or EU MDR pathways. That includes early feasibility, confirmatory clinical investigations, and post-market clinical follow-up when residual risk or notified body questions demand more data. We treat the clinical investigation plan as a living link between intended use, risk management, and what sites can actually execute.

Device trials differ from drug studies in how endpoints, investigational product control, and site training are handled. We pay attention to IFU clarity, investigator qualification, adverse event definitions tied to device performance, and how clinical data will feed the clinical evaluation report. When a study is multi-country, we help align ethics submissions, competent authority notifications, and monitoring so site files stay inspection-ready. Device accountability, complaint linkage, and procedure training records get the same scrutiny as eCRF completeness.

Engagements often include protocol and CIP review, site activation support, monitoring oversight, and clinical quality checks against the DHF and risk management file. We also help teams prepare for clinical audits and inspection questions that probe whether the study design actually supports intended use and labeling claims. If a CRO is running the investigation, we help you define sponsor oversight that is visible in the TMF, not only in email threads.

As evidence packages mature, we help connect clinical outputs to CER updates, PMCF plans, and labeling discussions so clinical operations and regulatory writing stay on the same facts. The aim is evidence that reviewers can follow from protocol to patient-level data without gaps in justification.

Medical device clinical support commonly includes

• CIP and protocol alignment to intended use claims
• ISO 14155-oriented monitoring and site oversight
• Investigator and site training readiness checks
• Adverse device effect and complaint linkage review
• PMCF and clinical evaluation data planning
• TMF and site file completeness for device trials
• Audit and inspection preparation for clinical evidence

If your device program needs clinical evidence that regulators and notified bodies can follow, we help structure the study work so operations, documentation, and claim support stay connected through close-out.