Guidelines for Failure Modes and Effects Analysis for Medical Devices

Summary

Presents guidelines that focus on failure modes and effects analysis (FMEA) and its application throughout the life cycle of a medical device. This book outlines the major US and EU standards and regulations. It presents an overview of risk management and risk analysis methodologies, and common FMEA pitfalls.

Product details

• Authors: Dyadem Press, Dyadem (Richmond Hill Press, Press Dyadem
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 28.06.2018
• EAN: 9781138464100
• ISBN: 978-1-138-46410-0
• No. of pages: 190
• Subjects: Natural sciences, medicine, IT, technology > Technology > General, dictionaries; TECHNOLOGY & ENGINEERING / Quality Control, TECHNOLOGY & ENGINEERING / Industrial Engineering, TECHNOLOGY & ENGINEERING / Electrical, Materials science, Engineering: general, Production & quality control management, Mathematics & science, Mathematics and science, TECHNOLOGY & ENGINEERING / Materials Science / General, Production and quality control management