Medical Device Quality Systems Manual

  醫療器械質量體系手冊

  A Small Entity Compliance Guide First Edition (Supersedes the Medical Device Good Manufacturing Practices [GMP] Manual)

  小實體企業認證指南第一版(用于取代原醫療器械GMP手冊)

  Chapters

  章節

  Cover page, Preface, Foreword

  首頁，前言

  Table of Contents

  目錄

  1. The Quality System Regulation

  1. 質量體系法規

  2. Quality Systems

  2. 質量體系

  3. Design Controls

  3. 設計控制

  4. Process Validation

  4. 流程驗證

  5. Personnel and Training

  5. 人員和培訓

  6. Buildings and Environment

  6. 建筑和環境

  7. Equipment and Calibration

  7. 設備和校準

  8. Device Master Record

  8. 器械主記錄

  9. Document and Change Control

  9. 文檔和變更控制

  10. Purchasing and Acceptance Activities

  10. 采購和接收活動

  11. Labeling

  11. 標簽

  12. Product Evaluation

  12. 產品評價

  13. Packaging

  13. 包裝

  14. Storage, Distribution and Installation

  14. 存儲，分發和安裝

  15. Complaints

  15. 投訴

  16. Servicing

  16. 售后服務

  17. Quality Systems Audits

  17. 質量體系審計

  18. Factory Inspections

  18. 工廠檢查

  19. Appendices

  19. 附件

  Cover page, Preface, Foreword

  HHS Publication FDA 97-4179

  首頁，前言

  MEDICAL DEVICE QUALITY SYSTEMS MANUAL:

  A SMALL ENTITY COMPLIANCE GUIDE

  First Edition

  (Supersedes the Medical Device Good Manufacturing Practices Manual)

  Andrew Lowery, Judy Strojny, and Joseph Puleo

  Division of Small Manufacturers Assistance

  Office of Health and Industry Programs

  CENTER FOR

  DEVICES AND

  RADIOLOGICAL HEALTH

  CDRH

  December 1996

  (This publication supersedes FDA 91-4179)

  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

  Public Health Service

  Food and Drug Administration

  Center for Devices and Radiological Health

  Rockville, Maryland 20850