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Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
Massachusetts Institute of Technology
Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
Medical Device Regulations Global Overview And Guiding PrinciplesJacobe2008
WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
Statistical Issues In Medical Device TrialsJacobe2008
Authors:
George Koustenis,
FDA-CDRH
David Breiter,
Boston Scientific
Roseann White,
Abbott Vascular
George Woodworth, Univ. of Iowa
FDA/INDUSTRY STATISTICS WORKSHOP: Washington, D.C. Sept. 29, 2006