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CSA PLUS 13485 : 2006

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CSA PLUS 13485 : 2006

THE ISO 13485 ESSENTIALS - A PRACTICAL HANDBOOK FOR IMPLEMENTING THE ISO 13485 STANDARD FOR MANUFACTURERS OF MEDICAL DEVICES

Canadian Standards Association

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Table of Contents

Preface
The Layout of this Handbook
PLUS 13485 - The ISO 13485 Essentials
Appendices
1 - Vocabulary Clause - ISO 9000:2000, ISO 13495:2003, and
    ISO 19011:2002
2 - Correspondence between ISO 13485:2003 and
    ISO 13485:1996
3 - Terms used in certain regulatory administrations to
    describe documents referenced in this Technical Report
4 - Contacts

General Product Information

Document Type Standard
Status Current
Publisher Canadian Standards Association
Supersedes
  • CSA PLUS 9001MD : 1998