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Guidelines for FMEA for Medical Devices
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More Information 		Quality assurance professionals in medical device manufacturing industry will find this comprehensive overview of Failure Mode and Effects Analysis to be an indispensable resource. The Guidelines examine why FMEA has become a powerful and respected analytical technique for effectively managing and reducing risks. Readers will learn how to use FMEA throughout the life cycles of their products to improve product quality and reliability and assure safety and regulatory compliance.

This comprehensive work examines various types of analysis, including Product/Design FMEA, Process FMEA, Service FMEA, and Application FMEA. The Guidelines provide solid advice on selecting a study team, setting up and conducting a study and analyzing the results.
Other topics include Failure Mode, Effects and Criticality Analysis (FMECA), and Product Quality Control Plans. Medical device manufacturers will come away from this work with a thorough understanding of how to harness the incredible potential of FMEA to improve the quality and reliability of their products.
A general overview of the topics discussed in this manual are:

  • Introduction and general overview of basic FMEA concepts, including the role of team work and management
  • Overview of the major U.S. and E.U. standards and regulations including ISO 14971, GMP and the ISO 9000 series
  • Analysis and risk guidelines of different types of FMEA, such as Product/Design FMEA, Process FMEA, Application FMEA and Service FMEA
  • Overview of Failure Modes Effects and Criticality Analysis (FMECA)
  • Product control and FMEA, with information on Control Plans and recommendations for what to do after an FMEA study
  • Software demonstration featuring FMEA software from Dyadem