AAMI SW87 : 2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS
Hardcopy , PDF
04-16-2018
English
01-01-2012
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Glossary of equivalent standards
Committee representation
Foreword
1 Introduction
2 Quality management system
3 Glossary
4 Acronyms
5 References
Specifies the importance of and provides guidance on the implementation of quality management systems to the design, development, provision, and support of medical device data systems as defined by the U.S. Food and Drug Administration (FDA).
| Committee |
WG 01
|
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Withdrawn
|
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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