ISO 13485 2003Translated into Plain EnglishTITLE 45: TABLE OF CONTENTS |
ISO 13485 is a Quality Management Standard for Medical Devices
| PART | TABLE OF CONTENTS | PAGE |
| 1 | Introduction | 3 |
| 2 | Approach | 6 |
| 3 | Terminology | 16 |
| 4 | Systemic Requirements | 26 |
| 5 | Management Requirements | 35 |
| 6 | Resource Requirements | 45 |
| 7 | Realization Requirements | 54 |
| 8 | Remedial Requirements | 83 |
| 9 | Summary of Requirements | 99 |
| 10 | Legal and Contact Information | 103 |
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| How to Order | Detailed Site Map | Alphabetical Index | |
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| OTHER ISO 13485 WEB PAGES |
|
Introduction to ISO 13485 Quality System Standard for Medical Devices |
| Definitions for ISO 13485 Quality Standard for Medical Devices |
| Plain English Overview of ISO 13485 2003 Quality Standard |
| ISO 13485 2003 Standard Translated into Plain English |
| How to Develop an ISO 13485 Quality Management System |
| ISO 13485 is a Quality Management Standard for Medical Devices |
| CONTACT INFORMATION |
| Praxiom Research Group Limited 9619 - 100A Street, Edmonton, Alberta, T5K 0V7, Canada Phone: (780)461-4514 Fax: (780)463-6034 info@praxiom.com |
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This web page was updated on May 22, 2007
