Excellence Beyond Compliance : Establishing a Medical Device Quality System (Hardcover)

Preface. A Compliance Story

Introduction

Chapter 1. The Challenge

Chapter 2. The Path

Chapter 3. Key Decisions

Chapter 4. A Quality Plan

Chapter 5. Documentation, the Big Picture

Chapter 6. Level 1 Documentation

Chapter 7. Level 2 Documentation

Chapter 8. Level 3 Documentation

Chapter 9. Level 4 Documentation

Chapter 10. Fully Incorporating Risk Management

Chapter 11. Implementation

Chapter 12. Maintenance (and Improvement)

Appendix A. Pharmaceutical Quality System Models

Appendix B. Addressing the Annex SL Model

Appendix C. Example Level 2 Procedures

Appendix D. Example Level 3 Flow Chart Procedure

Appendix E. Example Level 3 Playscript Procedure