This insight brief provides a roadmap for medical device manufacturers seeking global regulatory approval. IQVIA MedTech experts explain how sponsors can design clinical studies that simultaneously satisfy regulatory requirements across the United States, European Union, Japan, and other key markets. The paper covers regulatory planning, early agency engagement, harmonized study design, real-world evidence strategies, statistical considerations, and lifecycle regulatory management. By integrating regulatory and clinical development strategies from the outset, manufacturers can reduce costly rework, streamline submissions, and increase the likelihood that a single clinical program can support multiple international market authorizations.

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