Reliable Design of Medical Devices

Reliable Design of Medical Devices

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Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.This documentation is generally in the format of a Quality Manual. ... A sample of a Quality Manual Table of Contents includes: Cross Reference List A cross reference list of company documentation that addresses each clause of the ISOanbsp;...

Title:Reliable Design of Medical Devices
Author: Richard C. Fries
Publisher:CRC Press - 1997-01-30

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