GMP/Quality Systems
Search Results
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AAMI/ISO 13485:2003/(R)2009
This document has been replaced. View the most recent version.
Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 06/18/2003.
Languages: English
Historical Editions: AAMI/ISO 13485:2016/(R)2019, AAMI/ISO 13485:1996
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AAMI/ISO 13485:2016/(R)2019
Medical devices - Quality management systems - Requirements for regulatory purposes
standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 03/25/2016.
Languages: English
Historical Editions: AAMI/ISO 13485:2003/(R)2009, AAMI/ISO 13485:1996
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AAMI CE-293
The CE Mark: Understanding the Medical Device Directive
Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 01/01/1997.
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Design Control Guidance for Medical Device Manufacturers
Book by Association for the Advancement of Medical Instrumentation, 03/11/1997.
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AAMI GMP1.5
GMP Manual 5th edition - Complying with FDA Good Manufacturing Practice requirements: How to develop your Quality Systems Manual
Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 02/01/1997.
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Current Issues in Medical Device Quality Systems
Book by Association for the Advancement of Medical Instrumentation, 11/01/1996.
Languages: English
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The Quality Systems Compendium
This document has been replaced. View the most recent version.
Book by Association for the Advancement of Medical Instrumentation, 05/01/1998.
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Historical Editions: The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition, The Quality System Compendium: GMP Requirements and Industry Practice, 2nd Edition
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Do it by design: An introduction to human factors in medical devices
Book by Association for the Advancement of Medical Instrumentation, 12/01/1996.
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The Medical Device Directives: A Manufacturers' Handbook
Book by Association for the Advancement of Medical Instrumentation, 08/01/1996.
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Medical Device Quality Systems Manual: A small entity compliance guide [ Withdrawn ]
Book by Association for the Advancement of Medical Instrumentation, 03/01/1997.
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