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Glossary Term
Early Feasibility Study
Definition
An Early Feasibility Study (EFS) is a small-scale clinical study conducted during the early stages of medical device development. It focuses on evaluating the initial safety and device functionality in a limited number of patients. EFS allows manufacturers to assess design concepts, make refinements, and identify potential risks before advancing to larger-scale pivotal trials.
Relevance to the MedTech Industry
The EFS process facilitates innovation by enabling early-stage evaluation of novel medical devices in human patients. It provides critical data to guide design optimization, risk management, and regulatory strategies, helping manufacturers address potential issues early in the development lifecycle.
Additional Information & Related Terms
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