Guidelines for failure modes and effects analysis for medical devices

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Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis.

Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

Glossary	p. i
Chapter 1 Introduction	p. 1
Chapter 2 Regulations & Standards Governing Medical Device Manufacturing	p. 1
Background	p. 1
United States Regulations	p. 2
European Union Regulations	p. 5
International Standards	p. 7
EU/EC EN (European Norm) Standards	p. 11
Chapter 3 Risk Management of Medical Devices	p. 1
Risk Management	p. 1
Chapter 4 Risk Analysis Methodologies	p. 1
Hazard And Operability Analysis (HAZOP)	p. 1
Fault Tree Analysis (FTA)	p. 4
Chapter 5 Overview of FMEA	p. 1
Overview	p. 1
Limitations of FMEA	p. 7
Chapter 6 FMEA Procedures	p. 1
Introduction	p. 1
FMEA Terminology	p. 1
FMEA Steps	p. 8
Preliminary Consideration of FMEA	p. 11
Preparation Before FMEA Sessions	p. 13
Conducting FMEA Sessions	p. 16
Follow-Up of FMEA	p. 17
Chapter 7 FMEA Team	p. 1
Introduction	p. 1
Team Size	p. 1
Team Membership	p. 1
Team Leader (Facilitator)	p. 2
Chapter 8 Pitfalls with FMEA	p. 1
Chapter 9 Common Tools Used with FMEA	p. 1
Process Mapping/Process Flowcharts	p. 1
Block Diagrams/Functional Flow Diagrams	p. 4
Pareto Charts	p. 6
Chapter 10 Product Life Cycle & FMEA	p. 1
Introduction	p. 1
Different Types of FMEAs	p. 4
Integration of FMEA and Control Plan to Product Cycle	p. 7
Chapter 11 Product/Design FMEA	p. 1
Objectives	p. 1
Recommended Team Members	p. 2
Recommended Information in the Product/Design FMEA	p. 3
Worksheet
Suggested Risk Guidelines for Product/Design FMEA (D-FMEA)	p. 7
Chapter 12 Process FMEA	p. 1
Objectives	p. 1
Recommended Team Members	p. 2
Recommended Information in the Process FMEA	p. 2
Worksheet
Suggested Risk Guidelines for Process FMEA (P-FMEA)	p. 7
Chapter 13 Application FMEA	p. 1
Objectives	p. 1
Recommended Team Members	p. 2
Recommended Information in the Application FMEA	p. 2
Worksheet
Suggested Risk Guidelines for Application FMEA (A-FMEA)	p. 7
Chapter 14 Service FMEA	p. 1
Objectives	p. 1
Recommended Team Members	p. 1
Recommended Information in the Service FMEA	p. 2
Worksheet
Suggested Risk Guidelines for Service FMEA (S-FMEA)	p. 7
Chapter 15 Post FMEA Study	p. 1
Chapter 16 Control Plans	p. 1
Introduction	p. 1
Benefits of Developing and Implementing Control Plans	p. 1
Information Used to Develop Control Plans	p. 2
Control Plan Terminology and Recommended Information to Include	p. 2
Chapter 17 Overview of Failure Mode, Effects, and Criticality Analysis (FMECA)	p. 1
Overview of Criticality Analysis	p. 1
Criticality Analysis Terminology	p. 3
Criticality Worksheet/Report Format	p. 6
References	p. I

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