ASQ - Biomedical Division

Newsletter

BioFeedback September 2016

by ASQ Biomedical Division

Hello Biomed Division Members!, Recap of Xavier MedCon, Feingold Scholarship Awarded to Five Miami University Students, What Is My Failure Rate?, Biomedical Division Officers, Call for Articles, LinkedIn.

  • Filetype: pdf
  • Publish date: 2016-09

BioFeedback January 2016

by ASQ Biomedical Division

This issue delves into the criticality of supplier audits, UDI and the new version of 13485. David Manalan shares his CBA Glossary that any quality engineer will find useful.

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  • Publish date: 2016-01

BioFeedback August 2015

by ASQ Biomedical Division

This issue discusses the process for developing a new standard with updates on ISO 13485 and Supplier Quality Management.

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  • Publish date: 2015-08

BioFeedback March 2015

by ASQ Biomedical Division

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  • Publish date: 2015-03

BioFeedback October 2014

by ASQ Biomedical Division

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  • Publish date: 2014-10

BioFeedback May 2014

by ASQ Biomedical Division

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  • Publish date: 2014-05

Biofeedback: June 2013

by ASQ Biomedical Division

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  • Publish date: 2013-06

Biofeedback: March 2013

by ASQ Biomeidcal Division

Standards Central: Standards Identification 101, WCQI 2013: Managing Change, Education Initiatives 2013: The Year of the Audit, The Certified Biomedical Auditor Exam Has Been Revised!, Discussion Group Spotlight,

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  • Publish date: 2013-03

Biofeedback: March 2011

by ASQ Biomedical Division

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  • Publish date: 2011-03

BioFeedback April 2010

by ASQ Biomedical Division

World Conference Banquet Event: Skyline Dinner Cruise, ASQ and Standards, New England Biomedical Discussion Group Conference, Call for Nominations, FDA Warning Letters and Trends From 2009 and Where to Go for Information in 2010...

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  • Publish date: 2010-04

BioFeedback December 2009

by ASQ Biomedical Division

CBA Exam Review Course, FDA Enforcement in 2010, GHTF Overview and Update, Division Events in 2010..

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  • Publish date: 2009-12

BioFeedback: June 2009

Supplier and Process Quality Conference, Certified Biomedical Auditor (CBA) Exam, Grand Recipient, 2009 WCQI, Purchasing Controls, Biomedical Contributes..

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  • Publish date: 2009-06

BioFeedback: January 2009

January 2009

by ASQ Biomedical Division

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  • Publish date: 2009-01

BioFeedback: February 2008

Feb-2008

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  • Publish date: 2008-02

BioFeedback: July 2007

Jul-2007

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  • Publish date: 2007-07

BioFeedback: March 2007

Mar-2007

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  • Publish date: 2007-03

BioFeedback: Summer 2006

Summer 2006

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  • Publish date: 2006-06

BioFeedback: Fall 2005

Fall 2005

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  • Publish date: 2005-09

BioFeedback: Spring 2005

Spring 2005

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  • Publish date: 2005-03

Biofeedback Winter 2004-05 Vol 34 No. 4

by ASQ Biomedical Division

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  • Publish date: 2005-01

BioFeedback: Winter 2004

Winter 2004

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  • Publish date: 2004-12

BioFeedback: Fall 2004

Fall 2004

In this Issue: Sue Jacobs, past Chair, becomes ASQ National Director, Outstanding Risk Management Seminar in California, FDA Hot Topics seminar February 28 & March 1, Eastern Michigan MS Degree in Quality

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  • Publish date: 2004-09

BioFeedback: Summer 2004

Summer 2004

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  • Publish date: 2004-06

BioFeedback: Spring 2004

Spring 2004

In this Issue: Parting words from the Chair, Biomedical Division earns McDermond Top Achiever, Update from Rocky Mountain Discussion Group, Changes in the ASQ Membership approach

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  • Publish date: 2004-03

BioFeedback: Winter 2004

Winter 2004

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  • Publish date: 2004-01

BioFeedback: Fall 2003

Fall 2003

In This Issue: The ON-Line Registration Option, ISO 13485 Conference in London, UK, MedTech Investors Conference, An Excerpt from: Advanced Technologies to Lower the Cost of Healthcare and Improve Quality

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  • Publish date: 2003-09

BioFeedback: Summer 2003

Summer 2003

In This Issue: ISO 13485 West Coast conference highlights, Biomedical activities at AQC 2003, Software Validation and Development seminar in New England

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  • Publish date: 2003-06

BioFeedback: Spring 2003

Spring 2003

In This Issue: NE Discussion group initiates dinner meetings and discussions, ISO 13485 Seminar sold-out! To be repeated in SF, late June, Miami University designs Neonatal Transport System using Division grant, "Back to the Basics" presentations availabl

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  • Publish date: 2003-03

BioFeedback: Winter 2002

Winter 2002

In This Issue: Transitioning to ISO 13485 / 2003 2-Day Seminar, February 24-25, NEBDG Seminar: All About IVD's - The U.S. and Europe, FDA Update, RMBDG, 14th International Quality Conference in Jerusalem!

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  • Publish date: 2002-12

BioFeedback: Fall 2002

Fall 2002

In This Issue: Plans and accomplishments at the Annual Meeting, Understanding FDA Inspections, Summary, Feb. 24 & 25 - Save the Dates!

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  • Publish date: 2002-09

BioFeedback: Summer 2002

Summer 2002

In This Issue: Invitation to Preparers of Abbreviated 510 (k)s for Selected Devices, Update on ISO9001 and ISO13485 Harmonization of the Medical Device Quality Standards, AQC Highlights

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  • Publish date: 2002-06

BioFeedback: Spring 2002

Spring 2002

In This Issue, Back to basics-a huge success in Florida, Biomedical Division Banquet and session inforation for AQC, Biomedical Quality Auditor-update and details, Discussion groups go international

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  • Publish date: 2002-03

BioFeedback Winter 2001

by ASQ Biomedical Division

CQA Biomedical Certification, Conference, Sterilization: Control and Elimination of Microbes in Medical Devices,5th National Conference Quality in Compliance in the Next Millenium, A Mock-QSIT Audit of Ford and Firestone,..

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  • Publish date: 2001-12

BioFeedback: Fall 2001

Fall 2001

In This Issue, AQC presentation plans revealed!, Last call for "Back to Basics" in Florida for February, New contributor for NEBDG articles does 2, Update on the Bay Area discussion group

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  • Publish date: 2001-09

BioFeedback: Summer 2001

Summer 2001

In This Issue, ASQ-CQA-Biomedical certification process nears completion, first exam March 2002, New discussion group in Minnesota, and other discussion groups news and events, Grant to QA/RA Program at Temple University

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  • Publish date: 2001-06

BioFeedback Spring 2001

by ASQ Biomedical Division

Investments in the Past, Present, and Future, Division Sessions,AQC 2001, CQA Biomedical Certification Development-Status Report, Recent New England Biomedical DG Seminars, To Err is Human and Whta are We Doing About It?, ISO Technical Committee 210 Latest Activities..

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  • Publish date: 2001-03

BioFeedback Winter 2000

by ASQ Biomedical Division

Standard Issues and Updates,FDA Update, Annual Division Business Meeting @ Indianapolis AQC,Biomedical Division Replacement Services Update,The QSIT Sampling Tables,Design and Validation of Sterile Packaging for the Medical Device Industry...

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  • Publish date: 2000-12

BioFeedback Summer 2000

by ASQ Biomedical Division

FDA Hot Spots: A Review of Current FDA Medical Device Issues,Use the QSIT Sampling Tables at Your Own Risk, Conference Update, Denver Discussion Group, Quality Standards At The Crossroads..

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  • Publish date: 2000-06

BioFeedback Spring 2000

by ASQ Biomedical Division

AQC 2000-Indianapolis,FDA Update: Meeting GHTF Guidelines, CQA-Biomedical certification Progresses,Comments Concerning the Implementation of 21 CFR Part 11,Process Validation for the Medical Device Industry, new Publications from Quality Press...

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  • Publish date: 2000-03

BioFeedback Winter 1999

by ASQ Biomedical Division

Quality Today,Industry and FDA combine Training Session on 21 CFR Part 11, Challanges & Lessons in Design Control,Surf's Up at ACQ'99,..

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  • Publish date: 1999-12

BioFeedback Fall 1999

by ASQ Biomedical Division

CBQA Development Progresses,Who Want To Be A Millionaire?, ASQ 2000 Indianapolis,Indiana, Standards Update, QSIT- Quality System Inspection Technique Workshops, Introduction to Risk Management, Moving from Conformance to Performance, How Good Is Your Measuring System?..

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  • Publish date: 1999-09

BioFeedback Summer 1999

by ASQ Biomedical Division

re-Enigneering the Registration and Listing process,Quality Systems Inspection Strategy(QSIT): A New Inspection Stratagy, Surfin' Into The Next Millennium:A Summary Report from California,Global Quality in the New Millennium...

  • Filetype: pdf
  • Publish date: 1999-06

BioFeedback Winter 1998

by ASQ Biomedical Division

FDA/FDLI Medical Devices,Quality Planning, New Senior Management Responsibilities from the Quality System Regulations, Medical Devices: Report of Corrections and Removals,..

  • Filetype: pdf
  • Publish date: 1998-12

BioFeedback Fall 1998

by ASQ Biomedical Division

New CQAs at CDRH, Biomedical Division Proposes New ASQ Certification, ISO 9000:2000 Revisions to the Family of Standards, ISO 9000 in Health Care..

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  • Publish date: 1998-09

BioFeedback Summer 1998

by ASQ Biomedical Division

Call For Speakers,First China- U.S. Conference on Quality,A Report on the FDA Open Public Meeting-Quality System Inspection Technique(June18,1998), AQC'98- The Quality Revolution, Is Your Quality System Implementation Stalled?, Cpk and Other Statistical Methods Used in Process Validation..

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  • Publish date: 1998-06

BioFeedback Spring 1998

by ASQ Biomedical Division

Design Control Open Meeting,Annual Meeting ASQ, Standards Development: The Harmonization on Quality Managment Systems and Quality Technologies, Electronic Record Requirements Summary..

  • Filetype: pdf
  • Publish date: 1998-03

BioFeedback Winter 1997

by ASQ Biomedical Division

Implementing an Effective Internal Audit System that Meets Both FDA and ISO Requirements, Strategic Planning Committee Meets,Management's Responsibilitiess in the FDA's Quality System Requirements, AQC 1997 Biomedical Division Session Implementing Design Controls: A business Prespective..

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  • Publish date: 1997-12

BioFeedback Fall 1997

by ASQ Biomedical Division

Quality Press,College grants awarded,Biomedical Division's 1998 Annual Meeting and Dinner,FDA/FDLI medical Devices, The McDermond Program, regulatory Affairs Committee Activities..

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  • Publish date: 1997-09

BioFeedback Fall 1996

by ASQ Biomedical Division

Introducing the ASQ Biomedical Division Officers,Biomedical Division's College Grant program, National and International Standards: Strategic Planning for the 211st Century, Regional Councilor News..

  • Filetype: pdf
  • Publish date: 1996-09

BioFeedback Summer 1996

by ASQ Biomedical Division

Welcome to the New year 1996-1997,Biomedical Division Strategic Plan,Technical Files Seminar, The New Medcial Device Reporting (MDR) Regulation..

  • Filetype: pdf
  • Publish date: 1996-06

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