AAMI has several publications that will assist Quality System professionals in their compliance with FDA regulations and international standards. Links to these documents are provided below.

• Quality System Definitions (MEMBERS ONLY)
• Quality System Acronyms (MEMBERS ONLY)
• The Quality System Compendium, 2007
• Q Source CD
• FDA Training Videotapes

AAMI publishes Biomedical Instrumentation & Technology (BI&T), a bi-monthly peer-reviewed journal dedicated to the developers, managers, and users of medical instrumentation and technology. (MEMBERS ONLY)

• The Nuts and Bolts of Management Review, John Gagliardi – January/February 2007
• Outsourcing the Quality System, Vera Buffaloe – July/August 2006
• CAPA in the Modern Quality System, Christine Driscoll – November/December 2006
• Risk Management for IEC 60601-1 Third Edition, Edwin Bills – September/October 2006
• Effective Training Yields Learning and Growth, Joan Covino – March/April 2006
• Clearly Defined Design Input is Key to Product Development, Tammy Pelnik – January/February 2006
• Uses and Misuses of Probability in Medical Device Risk Management, Alan Kusinitz - September/October 2005
• The Critical Path to New Medical Devices, Binita Ashar, Mark Barnett, and Daniel Schultz - July/August 2005
• Importance and Benefits of MDR Reporting, Annette Hillring - May/June 2005
• Combination Products and the Role of Medical Device Firms. Robert Etheredge - March/April 2005
• How to Kick Start Your CAPA Process, Ken Peterson - January/February 2005
• How Higher Standards for Privacy, Security and Quality Will Change the Industry, Dave Vogel and Douglas Lichorwic- November/December 2004
• Process Validation: Achieving the Operational Qualification Phase, Vera Buffaloe - September/October 2004
• Understanding CAPA Requirements in a Software Context, Alan Kusinitz - May/June 2004
• Creating a Value Added Risk Management Approach, Carl Schmuland - September/October 2003
• Process Validation: Removing the Magic, Mystery, and Mayhem. Art Ward - July/August 2003
• Improving Product Introduction through Effective Design Reviews, Tammy Pelnik - March/April 2003

AAMI News is the association's official monthly newsletter that keeps members on top of AAMI standards activities and publications; key regulatory and legislative proposals and actions; and association programs, policies, and educational offerings. (MEMBERS ONLY)

• AAMI Launches Revised 13485 Course - June 2007
• New Ergonomics Standard to be Published in 2007 - June 2007
• Device Industry's Vital Risk Management Standard is Updated - May 2007
• Experts Offer Tips on Navigating the CAPA Maze - May 2007
• Medical Device Consultants: Getting Bang for Your Buck - November 2006
• Regulatory Expert Discusses Industry's Biggest Challenge - April 2006
• Devices Should be Supported by Human Factors - September 2005
• Integrating Risk Management Into Quality Systems - July-August 2005
• On the Benefits and Challenges of Regulatory Affairs - July-August 2005

Publications available outside of AAMI but relevant to Quality Systems professionals are listed below.

• Current Issues in Medical Device Quality Systems, 1997, AAMI, 256 pp., Link, D.M. and McDonnell, E. J. (eds.)
• Lean Thinking, 2003, Free Press, 396 pp. Womack, J.P. and Jones, D.T.
• Software Verification and Validation for Practitioners and Managers, 2ed, 2001, Artech House, 387 pp., Rakitin, S.R.
• The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, 1997, SOC Quality Press, 210 pp., Trautman, K.A.