Medical robotics FIH & EFS

Surgical & Medical Robotics CRO — First-in-Human and Early-Feasibility Studies in Latin America

bioaccess® is a first-in-human CRO purpose-built for MedTech startups, with deep experience running clinical studies of surgical, interventional, and autonomous medical-robotics systems. We help robotics innovators generate out-of-US (OUS) first-in-human and early-feasibility clinical evidence in Latin America — fast — to support their U.S. regulatory pathway (FDA Pre-Sub, IDE/IRB) and investor milestones.

Why Latin America for robotics FIH/EFS

Speed. Ethics-committee and regulatory approvals in 4–8 weeks vs. 6–12 months in the US/EU.
OUS data that supports US submissions under 21 CFR 812.28.
30–40% lower cost; experienced robotics-capable sites and proctoring.
End-to-end: regulatory strategy and submission (INVIMA and other LATAM agencies), site activation, device importation and logistics, physician training and proctoring, clinical monitoring, and data management.

Featured case — Perceptive Technologies (autonomous robotic dentistry)

bioaccess® executed the first-in-human "crown preparation" study for Perceptive Technologies' autonomous robotic dentistry system in Colombia. bioaccess® led regulatory navigation, site activation, and FIH study execution, generating OUS clinical evidence while Perceptive advances its U.S. regulatory pathway. A peer-reviewed journal article on the FIH study has been in preparation.

Additional robotics programs

bioaccess® has also supported a U.S.-based medical-robotics company, under confidentiality, with regulatory submission and clinical site activation for a study in Latin America.

"Your LatAm clinical study management expertise has been tremendously helpful and has served as the constant guiding light as we dared to navigate through this unknown territory for our team. Needless to say, bioaccess will be our preferred choice for the CRO for any future studies we may consider in Latin America."

— A U.S.-based medical-robotics company (name withheld at the client's request)

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