医疗器械质量手册(英文原版)..doc

Medical Device Quality Systems Manual 医疗器械质量体系手册 翻译人：胡宇山 QQ E-MAIL: huyushan@ 本资料为个人在工作之余翻译完成，只完成了主要内容的翻译，由于个人的英文的水平有限，还请同行的老师给与提出指正，共同学习进步。谢谢！ A Small Entity Compliance Guide First Edition (Supersedes the Medical Device Good Manufacturing Practices [GMP] Manual)? 小企业符合法规指南第一版（补充医疗器械良好生产规范手册） This page provides information and access to this CDRH manual as individual chapters as shown below: -以下部分为CDRH手册各章节内容信息： Chapters章节 Cover page, Preface, Foreword - Medical Device Quality Systems Manual1?? 封面，引导语，序-医疗器械质量体系手册 Table of Contents - Medical Device Quality Systems Manual2?? 目录表-医疗器械质量体系手册 1. The Quality System Regulation3?? 1.质量体系规范 2. Quality Systems4?? 2.质量体系 3. Design Controls5?? 3.设计质量控制 4. Process Validation6?? 4.工艺验证 5. Personnel and Training7?? 5.人员和培训 6. Buildings and Environment8?? 6.厂房和环境 7. Equipment and Calibration9?? 7.设备和校验 8. Device Master Record10?? 8.产品主记录 9. Document and Change Control11?? 9.文件和变更控制 10. Purchasing and Acceptance Activities12?? 10.采购和接收活动 11. Labeling13?? 11.标签或标识 12. Product Evaluation14?? 12.产品评价 13. Packaging15?? 13.包装 14. Storage, Distribution and Installation16?? 14.产品储存，分销运输和安装 15. Complaints17?? 15.客诉或抱怨 16. Servicing18?? 16.器械服务或设备维护 17. Quality Systems Audits19?? 17. 质量体系审核 18. Factory Inspections20?? 18. 现场检查 19. Appendices21?? 19. 补充附件 Cover page, Preface, Foreword - Medical Device Quality Systems Manual 封面，引导语，序-医疗器械质量体系手册 HHS Publication FDA 97-4179 卫生和社会服务保障部出版 FDA 97-4179 MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE 医疗器械质量体系手册：小企业法规之南 First Edition 第一版 (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 （补充医疗器械良好生产规范手册） Andrew Lowery, Judy Strojny和 Joseph Puleo 卫生和行业规划项目辅助办公室小型企业部 CENTER FOR DEVICES AND RADIOLOGICAL HEALTH CDRH CDRH器械和放射健康中心 December 1996 1996年12月 (This publication supersedes FDA 91-4179) （FDA91-4179增