Medical Device Quality Systems Manual

  醫(yī)療器械質(zhì)量體系手冊(cè)

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

  小實(shí)體企業(yè)認(rèn)證指南第一版(用于取代原醫(yī)療器械GMP手冊(cè))

  Chapters

  章節(jié)

  Cover page, Preface, Foreword

  首頁，前言

  Table of Contents

  目錄

  1. The Quality System Regulation

  1. 質(zhì)量體系法規(guī)

  2. Quality Systems

  2. 質(zhì)量體系

  3. Design Controls

  3. 設(shè)計(jì)控制

  4. Process Validation

  4. 流程驗(yàn)證

  5. Personnel and Training

  5. 人員和培訓(xùn)

  6. Buildings and Environment

  6. 建筑和環(huán)境

  7. Equipment and Calibration

  7. 設(shè)備和校準(zhǔn)

  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(dòng)

  11. Labeling

  11. 標(biāo)簽

  12. Product Evaluation

  12. 產(chǎn)品評(píng)價(jià)

  13. Packaging

  13. 包裝

  14. Storage, Distribution and Installation

  14. 存儲(chǔ)，分發(fā)和安裝

  15. Complaints

  15. 投訴

  16. Servicing

  16. 售后服務(wù)

  17. Quality Systems Audits

  17. 質(zhì)量體系審計(jì)

  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