Chapter 5. Quality management and regulatory affairs

Chapters in this book

1. Frontmatter I
2. Preface V
3. Contents IX
4. Contributing authors XIV
5. List of Abbreviations XVII
6. Chapter 1. Biomaterials – characteristics, history, applications 1
7. Chapter 2. Types and properties of biomaterials 75
8. Chapter 3. Synthesis and process technology of biomaterials 251
9. Chapter 4. In vitro and in vivo performance of biomaterials and biomedical devices 369
10. Chapter 5. Quality management and regulatory affairs 451
11. Chapter 6. Future challenges, anticipated developments, and outlook 467
12. Appendix A. Standard specifications for biomaterials and biomedical devices 489
13. Appendix B. Current world market situation of biomaterials and biomedical devices 503
14. Appendix C. Socioeconomic role of biomaterials: the example of hip endoprostheses 511
15. References 515
16. Glossary 591
17. Index 607