Medical Device & Diagnostic Industry
Articles by Category - Quality
2007 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 | 1995 | 1994 | 1993 | 1992 | 1991 | 1990 | 1989 | 1988 | 1987 | 1986 | 1985 | 1984 | 1983 | 1982 | 1981 | 1980 | 1979
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2007
- (Cover Story: Outstanding Quality and Regulatory Teams) US Endoscopy: Revamped SOP Worth the Work, Maria Fontanazza (MDDI, Jun 2007, p. 48). Keywords: Regulatory Affairs.
- (Cover Story: Outstanding Quality and Regulatory Teams) Stereotaxis Inc.: From Scratch to Success, Maria Fontanazza (MDDI, Jun 2007, p. 48). Keywords: Regulatory Affairs.
- (Cover Story: Outstanding Quality and Regulatory Teams) Plexus Electronic Assembly: Consistent Procedures for Better Compliance, Erik Swain (MDDI, Jun 2007, p. 48). Keywords: Regulatory Affairs.
- (Cover Story: Outstanding Quality and Regulatory Teams) Life Recovery Systems: Lean and Mean Structure for Quick Approval, Erik Swain (MDDI, Jun 2007, p. 48). Keywords: Regulatory Affairs.
- (Cover Story: Outstanding Quality and Regulatory Teams) Ethicon Inc.: A Regulatory Approach Suited to Sutures, Erik Swain (MDDI, Jun 2007, p. 48). Keywords: Regulatory Affairs.
- (Cover Story: Outstanding Quality and Regulatory Teams) Cholestech Corp.: Quality College Imparts Valuable Lessons, Maria Fontanazza (MDDI, Jun 2007, p. 48). Keywords: Regulatory Affairs.
- (Cover Story: Outstanding Quality and Regulatory Teams) Baxa Corp: Greatness Thrust Upon Them, Heather Thompson (MDDI, Jun 2007, p. 48). Keywords: Regulatory Affairs.
- (Cover Story: Outstanding Quality and Regulatory Teams) AtriCure Inc.: A Small Company Sees the Big Picture, Lawrence Lloyd (MDDI, Jun 2007, p. 48). Keywords: Regulatory Affairs.
- (Cover Story: Outstanding Quality and Regulatory Teams) Balancing the Device World On their Shoulders, The Editors (MDDI, Jun 2007, p. 47). Keywords: Regulatory Affairs.
- (Product Development Insight) Assessing the Cost of Poor Quality, Daniel Olivier and Nancy Singer (MDDI, Jun 2007, p. 40). Keyword: Industry.
2002
- A Systems Engineering Approach to Requirements Validation, Trace Baker (MDDI, Jan 2002, p. 100).
2001
- Using Measurement to Improve Quality, Daniel Olivier (MDDI, Oct 2001, p. 84).
2000
- Is the U.S. Meeting the Global Harmonization Guidelines for Auditing Quality Systems, Tim Wells (MDDI, Oct 2000, p. 78).
- (Medical Plastics and Biomaterials) Profiling: The Missing Link in Measurement Technology, Jon Gamble (MDDI, Sep 2000, p. 106).
- (Quality) Validation of FDA's New Quality System Inspection Technique, Georgia Layloff (MDDI, Jan 2000, p. 128). Keyword: Validation.
1999
- (Quality) QSIT: The New Quality System Inspection Technique, Timothy Wells (MDDI, Oct 1999, p. 83). Keyword: QSIT.
- (Filters) Verifying Membrane Filter-Based Bacterial Removal Using Titer Reduction, Jane Janas (MDDI, Jul 1999, p. 81). Keyword: Filters.
- Quality and Productivity: Then and Now, Chuck Truby (MDDI, Jun 1999, p. 104). Keyword: Manufacturing.
- Sterilization Validation of an Isolator System, Anne Booth (MDDI, May 1999, p. 174). Keyword: Validation.
- EtO Sterilization: Microbiological Aspects of Process Validation, Susan Edel Satter (MDDI, Apr 1999, p. 85). Keywords: Process Validation.
1998
- Can Inspection Time Be Reduced? Developing a HACCP Plan, Steve Maschino (MDDI, Oct 1998, p. 64). Keyword: HACCP.
- Quid Pro Quo: FDA Pilot Program Needs Industry Support, Jennifer M. Sakurai (MDDI, Oct 1998, p. 14). Keyword: HACCP.
- (Help Desk) How to Schedule Verification and Validation, John Daley (MDDI, Jul 1998, p. 52). Keyword: Compliance.
- Conducting Process Validations with Confidence, Daniel L. Weese (MDDI, Jan 1998, p. 107). Keywords: Process Validation.
1997
- (Help Desk) Process Validation Requirements for Drugs and Devices, Robert Spencer (MDDI, Nov 1997, p. 62). Keyword: Validation.
- (Help Desk) Documenting a Failure Investigation, Anita Thibeault (MDDI, Oct 1997, p. 68). Keywords: Failure Investigation.
- (Letters) Using Statistical Analysis in Device Testing, Steven Walfish (MDDI, Sep 1997, p. 36). Keyword: Validation.
- Assessing Pass/Fail Testing When There Are No Failures to Assess, Thom R. Nichols (MDDI, Jun 1997, p. 97). Keyword: Validation.
- Validating with Confidence: Meeting Minimum Strength Specifications, Vaughan Weeks (MDDI, May 1997, p. 181). Keyword: Validation.
- (News) Safety Is Key to Product Quality, Productivity (MDDI, Apr 1997, p. 18). Keywords: Occupational Safety.
- (Letters) Enforcing Design Controls, Robert L. Kay (MDDI, Mar 1997, p. 37). Keywords: Design Controls.
- FDA Makes Quality the Rule (Part 2), W. Fred Hooten (MDDI, Feb 1997, p. 83). Keywords: Quality System Regulation.
- (Interview) Quality Systems: On the Fast Track Toward Implementation, Kim Trautman (MDDI, Feb 1997, p. 30). Keywords: Quality System Regulation.
- FDA Makes Quality the Rule, W. Fred Hooten (MDDI, Jan 1997, p. 114). Keywords: Quality System Regulation.
- "(Book Review) Quality Systems Are More Than Just Written Procedures (How to Fail a Quality Audit, by Mort Levin)", Jim Sandberg (MDDI, Jan 1997, p. 22). Keyword: Audits.
- "Behind the Scenes with Fred Hooten, QSR Specialist", Daphne Allen (MDDI, Jan 1997, p. 17). Keywords: Quality System Regulation.
1996
- Getting Compliant for the Global Market, Gunter Frey (MDDI, Nov 1996, p. 96). Keywords: ISO 9000.
- Intranets: Using Web Technologies in a Regulated Environment, Morteza Minaee (MDDI, Nov 1996, p. 46). Keywords: Internet Technologies.
- FDA Plans GMP Education Blitz, Greg Freiherr (MDDI, Oct 1996, p. 84). Keyword: GMP.
- Improving Quality with Integrated Statistical Tools, John S. Kim (MDDI, Oct 1996, p. 78). Keywords: Statistical Tools.
- (Interview) The Future of Medical Device Regulation: A Global Perspective, Gordon Higson (MDDI, Jul 1996, p. 36). Keyword: Standards.
- Conducting Cost/Benefit Analyses of Implementing Total Quality Management, Ashweni Sahni (MDDI, May 1996, p. 216). Keywords: Total Quality Management.
- Conducting Internal Audits: Taking the Company's Pulse, John Sawyer (MDDI, May 1996, p. 194). Keyword: Audits.
- The ISO 9000 Journey, Stephen L. Thoresen (MDDI, Mar 1996, p. 90). Keywords: ISO 9000.
1995
- (Guest Editorial) The Return on Investment from Quality, R. Ira Porterfield (MDDI, Sep 1995, p. 32). Keyword: TQM.
- Corrective Actions: Understanding, Developing, and Implementing a Closed-Loop System, Jim Sandberg (MDDI, May 1995, p. 102). Keywords: Quality Systems.
- A Quality Maturity Model for Medical Device Manufacturers, James P. Stout (MDDI, Feb 1995, p. 50). Keywords: ISO 9000.
- Closing the Loop on Nonconformance, Barbara-Helene Smith (MDDI, Jan 1995, p. 222). Keyword: GMPs.
- Using Reengineering Concepts to Improve Quality Systems, Anil Rastogi (MDDI, Jan 1995, p. 115). Keyword: TQM.
- Competing for Quality: How Japanese Manufacturing Principles Improved Critikon, Greg Freiherr (MDDI, Jan 1995, p. 108). Keyword: TQM.
1994
- Reengineering in FDA's Shadow, Greg Freiherr (MDDI, Dec 1994, p. 38). Keyword: GMPs.
- Key Elements for a Complaint-Handling System, Dale McMillen (MDDI, Oct 1994, p. 194). Keyword: GMPs.
- Simplifying Design of Experiments through Graphical Analysis, Gregory Stoddard (MDDI, Oct 1994, p. 80). Keywords: Process Validation.
- Design of Experiments for Small Manufacturers, Scott H. DeWitt (MDDI, Oct 1994, p. 77). Keywords: Process Validation.
- (News) Device Manufacturing Quality Standards Go Global (MDDI, Oct 1994, p. 12). Keyword: Standards.
- Components of a Validation Master Plan, Gale E. Van Buskirk (MDDI, Sep 1994, p. 154). Keywords: Process Validation.
- (Washington Wrap-Up) AAMI Gets ISO Committee, James G. Dickinson (MDDI, Aug 1994, p. 28). Keyword: Standards.
- Creating a Complete Change Control System, Gale E. Van Buskirk (MDDI, May 1994, p. 270). Keywords: Change Control.
- Qualification Testing: Considerations for a Comprehensive Program, James A. McLinn (MDDI, May 1994, p. 224). Keyword: Testing.
- (Interview) Enhanced Quality through Strategic Partnerships, Anil K. Rastogi (MDDI, May 1994, p. 58). Keyword: TQM.
- The Human Side of Auditing, Laura A. Halper (MDDI, Apr 1994, p. 102). Keyword: Audits.
- Analyzing Measurement Errors to Improve Calibration Procedures, Morteza Minaee (MDDI, Mar 1994, p. 138). Keyword: Calibration.
- (News) ISO Moves to Harmonize Medical Device Standards (MDDI, Mar 1994, p. 12). Keyword: Standards.
- (Washington Wrap-Up) New GMPs Emphasize Quality Design, James G. Dickinson (MDDI, Feb 1994, p. 32). Keyword: GMPs.
- Developing Change Control That Works, Wallis Weiler Cady (MDDI, Jan 1994, p. 242). Keywords: Change Control.
- What Constitutes a Complaint?, Edward T. Griffith (MDDI, Jan 1994, p. 162). Keyword: GMPs.
- Improving Process Quality through Trend Analysis, Ashweni Sahni (MDDI, Jan 1994, p. 103). Keywords: Trend Analysis.
- Corporate Structure and GMP Compliance, Richard M. Crompton (MDDI, Jan 1994, p. 80). Keyword: GMPs.
1993
- Workbench Auditing Can Improve GMP Awareness, Kathy Nusser (MDDI, May 1993, p. 238). Keywords: Training, GMPs.
- Model for Streamlined Product Development, Larry Blankenship (MDDI, May 1993, p. 134). Keywords: Preproduction QA.
- Bare Essentials for Internal Auditing (The), Stephen K. Sheng (MDDI, Apr 1993, p. 134). Keyword: GMPs.
- Simple Tools to Reinforce GMP Training, Lisa Peterson (MDDI, Feb 1993, p. 86). Keywords: Training, GMPs.
- Meaning of Quality (The): An Interview with Michael Cates and Michael DeMane of Smith & Nephew Richards, Inc., Memphis, TN, Michael Cates (MDDI, Feb 1993, p. 24). Keyword: Management.
- Improve Inspection Follow-Up with Statistical Tools, Suzanne G. Fiorino (MDDI, Jan 1993, p. 216). Keyword: GMPs.
- Establishing an Effective Calibration and Preventive Maintenance Program, David Warburton (MDDI, Jan 1993, p. 75). Keywords: Process Control, Instrument Calibration.
1992
- Improving process quality through variation research: Part II, Thomas S. Woods (MDDI, Aug 1992, p. 50). Keywords: Process Control, QA/QC.
- Techniques for performing vendor audits, Wallis Weiler Cady (MDDI, Jul 1992, p. 80). Keyword: Audits.
- Improving process quality through variation research, Thomas S. Woods (MDDI, Jul 1992, p. 66). Keywords: Process Control, QA/QC.
- Effects of CLIA '88 on IVD design and marketing, Kicab Castaneda-Mendez (MDDI, Jun 1992, p. 99). Keywords: CLIA88, Manufacturing, QA/QC, Laboratories.
- Achieving total quality management in the medical device industry, Pamela Hochman Norton (MDDI, Apr 1992, p. 34). Keywords: TQM, Management.
- News: Proposed GMP changes could undermine quality, industry official says (MDDI, Feb 1992, p. 10). Keywords: Audits, Inspections, GMPs.
- Installing an electronic document storage and retrieval system: a case study, Sanford A. Schram (MDDI, Jan 1992, p. 108). Keywords: Documentation, Information Management.
- Design of experiments made easy, Thomas J. Pepin (MDDI, Jan 1992, p. 100). Keywords: Process Control, Design Of Experiments.
1991
- Seizing control of product changes, Jeremy Bachmann (MDDI, Nov 1991, p. 44). Keywords: Change Control.
- In search of control, John Bethune (MDDI, Nov 1991, p. 8). Keywords: Process Control, Change Control.
- Perspectives on the design review, Jeremy Bachmann (MDDI, Oct 1991, p. 60). Keywords: Design Review.
- Design review: from the product's cradle to grave, Beatrice A. Salis (MDDI, Oct 1991, p. 58). Keywords: Design Review.
- How to conduct a failure mode and effects analysis: an interview with Ashweni Sahni, Senior Staff Specialist, Corporate Quality Assurance, Medtronic, Inc., Minneapolis, MN, Jeremy Bachmann (MDDI, Oct 1991, p. 18). Keywords: FMEA, Design Review, Failure Analysis.
- TQM 'reality check' for U.S. device companies (A), Floyd V. Edwards (MDDI, Oct 1991, p. 14). Keywords: Total Quality System, TQM, Management.
- Handling complaints systematically: the right approach, Barry V. Ashar (MDDI, Sep 1991, p. 53). Keywords: Complaints, Product Complaints.
- How to perform an effective audit, Wallis Weiler Cady (MDDI, May 1991, p. 44). Keyword: Audits.
- Decision dilemma: product change and field activity, James W. Morgan (MDDI, Mar 1991, p. 90). Keywords: Documentation, Failure Analysis, Change Control.
1990
- Developing a device manufacturing plan and a GMP/QA program, Wallis Weiler Cady (MDDI, Oct 1990, p. 60). Keywords: QA/QC, GMPs.
- GMP audits: pay now or pay later, Gale E. Van Buskirk (MDDI, Jul 1990, p. 54). Keywords: Audits, GMPs.
- New math-free SPC cuts scrap and rework costs, Martin R. Smith (MDDI, Jun 1990, p. 160). Keyword: SPC.
1989
- Era of corporate assurance (The), James W. Morgan (MDDI, Oct 1989, p. 16). Keyword: Management.
- Auditing by variables analysis: foiling Murphy's Law, Frank M. Gregorio (MDDI, Jun 1989, p. 108). Keywords: Audits, Variables Analysis.
- Control charts: a technique of process control, Edward G. Schilling (MDDI, Apr 1989, p. 46). Keywords: Process Control, Control Charts.
- Recall: a second chance, Leonard J. Stauffer (MDDI, Mar 1989, p. 60). Keyword: Recalls.
1988
- Building a quality culture, John A. DeLucia (MDDI, Dec 1988, p. 46). Keywords: TQM, Management.
- FMEA: a route to better devices, Kathleen Doheny (MDDI, Oct 1988, p. 42). Keyword: FMEA.
- Designing quality in, Howard M. Holstein (MDDI, Oct 1988, p. 32). Keywords: Preproduction QA, Quality, Product Liability.
- Quality: overhead or profit center?, Bill Feingold (MDDI, Oct 1988, p. 10). Keywords: Professionals, Productivity.
- Making a commitment to total system quality, Frank P. Wilton (MDDI, May 1988, p. 8). Keywords: Total Quality System, TQM.
1987
- Intelligent manufacturing: a hot topic?, David Haut (MDDI, Oct 1987, p. 26). Keywords: Process Control, QA/QC, Automated QA.
- Preproduction quality assurance: no surprise, James W. Hartman (MDDI, Oct 1987, p. 10). Keywords: Preproduction QA, Design Review.
1986
- Quality audits: getting the most out of GMPs, Les Vincent (MDDI, Oct 1986, p. 54). Keywords: Audits, GMPs.
- Statistical process control: preventing package-seal failures, Bruce J. Schullo (MDDI, Oct 1986, p. 22). Keyword: SPC.
- MEDIQ: a modular expandable database for industrial quality, Bruce A. Janis (MDDI, Sep 1986, p. 34). Keywords: Configuration Control, Automated QA.
- Environmental stress screening of medical electronics products, Robert Mercado (MDDI, May 1986, p. 54). Keywords: Defect Detection, Environmental Stress Screening.
- Validation of computerized sterilization measurement and control systems, William F. Fitzgerald (MDDI, Feb 1986, p. 26). Keywords: Process Control, Software, Validation.
1985
- Quality, service, and costs: impacts on packaging, Carl D. Marotta (MDDI, Oct 1985, p. 24). Keywords: Costs, Management.
- Reweighting quality in the value equation, R. Ira Porterfield (MDDI, Oct 1985, p. 10). Keywords: Cost Containment, Customer Perception, Management.
1984
- Configuration control: why do it?, Dinesh Chandra (MDDI, Nov 1984, p. 10). Keywords: Configuration Control.
- Need for company-wide quality assurance programs (The), Stanley A. Marash (MDDI, Oct 1984, p. 10). Keywords: Total Quality System.
- Understanding software validation in automated systems, E. Ronald Atkinson (MDDI, Sep 1984, p. 10). Keywords: Validation, Software, Automated QA.
- Simplified control-code system for medical products (A), Frank S. Copeland (MDDI, Aug 1984, p. 30). Keywords: QA/QC, Control Numbers.
- Exploring QA computer systems, John R. Cornwell (MDDI, Mar 1984, p. 62). Keywords: Software, Automated QA.
- How GMPs regulate automated production, Alicia Abbott (MDDI, Mar 1984, p. 30). Keywords: Automation, Process Validation, Software, GMPs.
- Computer-generated defect report system (A), John Kendall (MDDI, Mar 1984, p. 16). Keywords: Defect Detection, QA/QC, Automated QA.
- LAL methodology: the choice is yours, Thomas J. Novitsky (MDDI, Jan 1984, p. 48). Keywords: LAL, Testing.
1983
- Product quality and capital investment: how much is enough?, Norm Best (MDDI, Mar 1983, p. 24). Keyword: Management.
1982
- Conducting an audit, Stanley A. Marash (MDDI, Dec 1982, p. 31). Keyword: Audits.
- Audit teams and planning, Stanley A. Marash (MDDI, Nov 1982, p. 58). Keyword: Audits.
- Filtration of serum protein products, Roger W. Norquist (MDDI, Nov 1982, p. 36). Keywords: Filtration, Blood Protein Products.
- Quality auditing, Stanley A. Marash (MDDI, Oct 1982, p. 56). Keywords: Documentation, Audits.
- Establishing an effective calibration program, Robert E. Bremmer (MDDI, May 1982, p. 39). Keywords: Instrument Calibration, GMPs.
1981
- Computers and quality assurance in a regulated industry, John Austin Keane (MDDI, Oct 1981, p. 44). Keywords: Documentation, Automated QA.
- Quality control circles, Stanley A. Marash (MDDI, Jun 1981, p. 42). Keywords: QCCircles, Training.
- Consider the independent laboratory, Edward F. Kelly (MDDI, Jun 1981, p. 38). Keywords: Testing, Laboratories.
- Product complaints and recalls: an overview of corporate considerations, Richard D. Hamill (MDDI, May 1981, p. 50). Keywords: Product Complaints, Recalls.
- Principles of process validation, Thomas H. Riggs (MDDI, May 1981, p. 31). Keywords: Documentation, Process Validation.
- ASQC 35th Annual Quality Congress, Ralph H. Dudley (MDDI, Apr 1981, p. 26). Keyword: ASQC.
1980
- GMPs and packaging suppliers, Carl D. Marotta (MDDI, Nov 1980, p. 22). Keywords: Vendors, GMPs.
- Hosting FDA inspectors, James W. Hartman (MDDI, Aug 1980, p. 34). Keyword: Inspections.
- Creative implementation of internal audits, Barney Anderson (MDDI, Jun 1980, p. 40). Keywords: Audits, Compliance, GMPs.
1979
- Documentation and GMP: how to reduce paperwork, Victor Goetz (MDDI, Oct 1979, p. 36). Keywords: Documentation, Audits, GMPs.
- Total-quality-system approach to devices (A), Allen M. Hans (MDDI, Jun 1979, p. 36). Keywords: Total Quality System, GMPs.
