Early Feasibility Studies (EFS) for Medical Devices — bioaccess®

bioaccess® manages early feasibility studies for medical devices in Latin America. The company states it delivers FDA IDE-ready data in 9–12 months at 30% lower cost than US/EU studies.

Service Description

Limited clinical investigations of new medical devices conducted early in development across Latin America. Studies are designed to generate FDA-accepted data under 21 CFR 812.28.

Key Features

• FDA IDE-ready study design and execution
• Regulatory submissions to INVIMA, COFEPRIS, ANVISA, and other agencies
• GCP/ISO 14155 compliant monitoring
• 30–50% cost savings vs. US/EU
• First patient in as fast as 6 months
• Sites pre-qualified for device studies

Discuss Your EFS