News & Insights From HCC...

ISO 14155:2026 raises expectations for how MedTech sponsors structure, document, and defend clinical safety oversight. The update reinforces the need for a risk-based, integrated safety model that connects clinical risk assessment, AE and device deficiency workflows, DMC/CEC governance, stopping rules, monitoring strategy, and inspection-ready documentation. Hart Clinical Consultants helps MedTech sponsors strengthen safety oversight models, committee governance, AE/device deficiency workflows, and inspection-ready documentation.

HCC guided an international MedTech start-up through the regulatory, ethical, and operational challenges of an Early Feasibility Study (EFS) at U.S. VA Medical Centers, proactively addressing EFIC requirements with key stakeholders to mitigate risks early.

Discover how HCC helped a global medical device company establish an international proctoring program for a novel breakthrough technology. Through strategic recruitment and training of local clinical experts across three continents, HCC provided real-time procedural guidance, ensuring successful device implantation, maintaining patient safety, and accelerating global study execution while reducing sponsor costs.

This case study demonstrates how HCC's agile clinical operations accelerated trial execution, enabling a PMA submission 2.5 months ahead of schedule and expediting market access for a novel medical device.