Guidelines for Failure Modes and Effects Analysis for Medical Devices

1. Auflage 2003
ISBN: 978-0-8493-1910-5
Verlag: Taylor & Francis Inc

Buch, Englisch, 190 Seiten, Format (B × H): 214 mm x 283 mm, Gewicht: 553 g

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.

Zielgruppe

Professional

Autoren/Hrsg.

Press, Dyadem (Richmond Hill, Ontario, Canada)

Press, Dyadem

Fachgebiete

• Technische Wissenschaften Sonstige Technologien | Angewandte Technik Medizintechnik, Biomedizintechnik
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Fertigungsverfahren der Präzisionsgeräte
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Spitzentechnologiesektor
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizintechnik, Biomedizintechnik, Medizinische Werkstoffe

Inhaltsverzeichnis

Glossary, CHAPTER 1 - Introduction, CHAPTER 2 - Regulations Standards Governing Medical Device Manufacturing, CHAPTER 3 - Risk Management of Medical Devices, CHAPTER 4 - Risk Analysis Methodologies, CHAPTER 5 - Overview of FMEA, CHAPTER 6 - FMEA Procedures, CHAPTER 7 - FMEA Team, CHAPTER 8 - Pitfalls with FMEA, CHAPTER 9 - Common Tools Used with FMEA, CHAPTER 10 - Product Life Cycle FMEA, CHAPTER 11 - Product/Design FMEA, CHAPTER 12 - Process FMEA, CHAPTER 13 - Application FMEA, CHAPTER 14 - Service FMEA, CHAPTER 15 - Post FMEA Study, CHAPTER 16 - Control Plans, CHAPTER 17 - Overview of Failure Mode, Effects, and Criticality Analysis (FMECA), References

Über Autor(innen)

Dyadem Press