QS Resources: Publications
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
- Quality System Collection 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. Articles on QS topics include: (MEMBERS ONLY)
- Integrating Risk Management into the CAPA Process, Ed Bills and Joseph Tartal - Nov/Dec 2008
- Controlling the Dynamics of Change in a Regulated Environment, John Gagliardi - Sep/Oct 2008
- Design Transfer and Successful Product Development, Jack Ward - Jul/Aug 2008
- Purchasing Controls: Best Practice Guidelines, John Gagliardi - May/Jun 2008
- Who's Monitoring Your Lab? Choosing the Right Facility Monitoring System, Megan Thibault - Mar/Apr 2008
- The Internal Quality Audit Process: Risk Indicators and Uncertainties, John Gagliardi - Jan/Feb 2008
- The Nuts and Bolts of Management Review, John Gagliardi – Jan/Feb 2007
- Outsourcing the Quality System, Vera Buffaloe – Jul/Aug2006
- CAPA in the Modern Quality System, Christine Driscoll – Nov/Dec 2006
- Risk Management for IEC 60601-1 Third Edition, Edwin Bills – Sep/Oct 2006
- Effective Training Yields Learning and Growth, Joan Covino – Mar/Apr 2006
- Clearly Defined Design Input is Key to Product Development, Tammy Pelnik – Jan/Feb 2006
- Uses and Misuses of Probability in Medical Device Risk Management, Alan Kusinitz - Sep/Oct 2005
- The Critical Path to New Medical Devices, Binita Ashar, Mark Barnett, and Daniel Schultz - Jul/Aug 2005
- Importance and Benefits of MDR Reporting, Annette Hillring - May/Jun 2005
- Combination Products and the Role of Medical Device Firms. Robert Etheredge - Mar/Apr 2005
- How to Kick Start Your CAPA Process, Ken Peterson - Jan/Feb 2005
- How Higher Standards for Privacy, Security and Quality Will Change the Industry, Dave Vogel and Douglas Lichorwic- Nov/Dec 2004
- Process Validation: Achieving the Operational Qualification Phase, Vera Buffaloe - Sep/Oct 2004
- Understanding CAPA Requirements in a Software Context, Alan Kusinitz - May/Jun 2004
- Creating a Value Added Risk Management Approach, Carl Schmuland - Sep/Oct 2003
- Process Validation: Removing the Magic, Mystery, and Mayhem. Art Ward - Jul/Aug 2003
- Improving Product Introduction through Effective Design Reviews, Tammy Pelnik - Mar/Apr 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. Articles on QS topics include: (MEMBERS ONLY)
- AAMI Kicks Off Quality System Online Group - June 2009
- AAMI Releases New Quality System Collection - May 2009
- FDA to Review Devices Marketed Prior to 1976 - May 2009
- Expert Details 2010 Changes to European Device Regulations - April 2009
- Speakers Provide Insight on Regulating Software as a Medical Device - April 2009
- Document Control, Records Management Take Center Stage - February 2009
- Experts Offer Tips for Error-Resistant Medical Devices - January 2009
- Experts Offer Best Practices on Design Transfer of Medical Devices - November 2008
- Design Control Course Headlines Fall Programs - September 2008
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, ASQC Quality Press, 210 pp., Trautman, K.A.