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Achieving EU and U.S. Commercialization Success: The Critical Linkage Between Reimbursement and Regulatory Strategies

This White Paper provides an overview and comparison of general regulatory and reimbursement frameworks for medical devices in the EU and U.S. Discussed within are recent regulatory adjustments in key legislation and revision guidance from authorities, resultant from the quickly shifting regulatory environment within the global medical device marketplace.

While the EU and U.S. markets offer varying opportunities for medical device manufacturers, they both present challenges on the path to reimbursement and regulatory approval. Thus, early integration and planning of requirements related to market access are key factors to success for sustainable market access in these regions.

NAMSA invites you to access this White Paper, developed in collaboration with Kalms Consulting, to better understand the industry’s reimbursement landscape, potential fragmentation between regulatory and reimbursement goals, possible routes to secure early technology adoption in specific global markets and achieving long-term market success via general or statutory reimbursement.

Please fill out the form below to access this white paper.

We also invite you to learn more about NAMSA’s Reimbursement Services by clicking here.