LATAM's Regulatory Framework For Medtech Early Feasibility Studies

U.S. medtech companies are increasingly searching for a destination where they can recruit patients faster, easier, and cheaper for their early feasibility studies. Medtech companies want to avoid the uncertainty of the FDA Investigational Device Exemption (IDE) review process. Due to the new European Medical Device Directive (MDR) 's difficulties since May 2021, the medtech clinical trial pendulum is shifting from Eastern Europe to Latin America. Many more medtech companies are now looking at Latin America as their destination for their early feasibility research instead of Eastern Europe.

Clinical Research, Clinical Trial, Investigación clínica, ColombiaJulio G. Martinez-ClarkNovember 11, 2022early stage clinical trial, early feasibility clinical trial, first-in-human, first-in-man, medical device clinical trial, regulatory frComment

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