10.1 Federal Regulation of Medical Devices 10.1.1 The Law (including amendments) 10.1.2 Organization of FDA 10.1.3 Classification of Devices 10.1.4 Process of Assessment 10.1.4.1 510(k)Substantial Equivalence 10.1.4.2 Premarket Approval 10.1.5 Clinical Trials (Investigational Device Exemption) 10.1.6 Labeling 10.1.7 Tripartite Biocompatibility Guidance 10.1.8 Standards 10.1.9 Good Manufacturing Procedures 10.1.10 Good Laboratory Practices 10.2 Clinical Trial Design
Foreword vi 8 Discovery 141 Preface to the Third Edition vii 9 Verification 163 Preface to the First Edition viii Ack COMMUNICATION nowled gments ix 1 Int roduction 1 10 Process 179 11 Individual Design 189 BASICSKILLS 12 Team Design 203 2 Drawing 17 13 Public Design 217 3 Conventions 39 14 Conclusion 231 4 Abst raction 55 Notes 237 5 Expression 67 Bibliography 239 Illustration Credits 242 APPLIED SK Index 244 ILLS 6 Analysis 81 7 Exploration 115
2.1 Functional Performance of the Device(and Attachment to Tissue) 2.1.1 Mechanical 2.1.1.1Strength and Modulus of Elasticity: Modulus Matching 2.1.1.2 Tribology 2.1.2.3 Kinematics 2.1.2 Chemical 2.1.2.1 Drug Delivery/Controlled Release System
Organizational Structure and Design Manager Subordinate Subordinate Subordinate Organizational Design Purposeful and goal-oriented process Decisions/actions to predetermine the way employees do their work Organizational structure Relatively stable relationships and processes of the organization
