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PubMed

Requirements to bring a medical device to market.

PMID: 39179465 ·

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JournalTrends in biotechnology
Year
PMID39179465

Abstract

A roadmap for medical device innovators is presented that highlights the essential steps for regulatory authorization, market access, and reimbursement strategies in the USA, with a focus on strategic planning for commercial success, underscoring the integration of regulatory and market access considerations from the initial development of a medical device.

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