Name: AAMI SW87 : 2012
Brand: AAMI
Price: 248.81 AUD

AAMI SW87 : 2012

Withdrawn

APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS

Available format(s)

Hardcopy , PDF

Withdrawn date

16-04-2018

Language(s)

English

Published date

01-01-2012

Publisher

Association for the Advancement of Medical Instrumentation

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Status	Withdrawn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