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1.Tierce J (2010) Evidence-Based Med 40–43
2.U.S. Food and Drug Administration, U.S. Department of Health and Human Services. Challenge and opportunity on the critical path to new medical products Report no 1. Rockville, MD, USA: U.S. Department of Health and Human Services, U.S. Food and Drug Administration; 2004
3.T Kucklick, The medical device R & D handbook (CRC Press, Taylor & Francis Group, LLC, Boca Raton, 2006).
4.Piezsch JB, Shluzas LA, Pate-Cornell ME, Yock PG, Linehan JH (2009) J Med Dev 3; 021004-1–0210014-15
5.S Zenios, J Makower and P Yock, Biodesign: the process of innovating medical technologies (Cambridge University Press, New York, 2010).

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