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Medical Device Development: Regulation and Law

2009 Edition

Parexel International Corporation

This publication, authored by Jonathan Kahan and members of Hogan & Hartson’s medical device practice, is a resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides a comprehensive and updated analysis of U.S. medical device and diagnostics development and approval requirements. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the U.S. The new edition of this resource addresses the latest regulatory and legal developments that guide how medical devices are developed today. Additional Hogan & Hartson chapter co-authors include:

• Robert Berlin
• Megan K. Doyle
• Jennifer Agraz Henderson
• Michael S. Heyl
• Lina R. Kontos
• Yarmela Pavlovic
• Randy J. Prebula
• Gerard J. Prud’homme
• John J. Smith
• Susan D. Tiedy-Stevenson
• Edward C. Wilson, Jr.
• Danielle C. Woodlee

For more information on this publication click here to visit the Web site. Also available at this link is a podcast interview with Jonathan Kahan discussing the content of the publication.


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