Medical Device Quality Assurance and Regulatory Compliance / Edition 1

Medical Device Quality Assurance and Regulatory Compliance / Edition 1

by Richard C. Fries, Fries Fries
     
 

ISBN-10: 0824701771

ISBN-13: 9780824701772

Pub. Date: 08/11/1998

Publisher: Taylor & Francis

This essential reference acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements. Medical Device Quality Assurance and Regulatory Compliance summarizes regulation

Overview

This essential reference acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements. Medical Device Quality Assurance and Regulatory Compliance summarizes regulation activities of the FDA, the European Economic Community, and the Global Harmonization Task Force shows how to choose a standard from the ISO 9000 and ISO 14000 series teaches how to prepare your company for auditing, how to choose a notified body, and how to survive the audit reviews standards dealing specifically with medical devices such as EN 46000, ISO 13485, and ISO 13488 discusses the requirements for product submittals prior to product introduction addresses current issues such as third party approvals and more! Including numerous key references, tables, and drawings, Medical Device Quality Assurance and Regulatory Compliance is ideal for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project managers; biomedical technicians; medical device purchasing personnel; and upper-level undergraduate and graduate students in these disciplines.

Product Details

ISBN-13:
9780824701772
Publisher:
Taylor & Francis
Publication date:
08/11/1998
Edition description:
ILLUSTRATE
Pages:
496
Product dimensions:
6.25(w) x 9.25(h) x 1.25(d)

Table of Contents

Background of standards and regulations: quality assurance and regulatory compliance; the FDA; the European Union; the global harmonization task force; software as a special case. Quality systems: the ISO 9000 series of standards; ISO 9000 requirements/ compliance; the ISO 14000 standard; ISO 14000 requirements/compliance. Quality devices: the EN46001 standard; EN46001 requirements/compliance; the ISO 13485 standard; ISO 13485 requirements/ compliance; IEC 601-1-4; IEC601-1-4 requirements/compliance; ISO 9000-3; ISO 9000-3 requirements/compliance; IEC601-1; IEC601-1 requirements/compliance. Regulation: the medical device directives; medical device directive requirements/compliance; the quality system regulations (QSR); QSR requirements/compliance. Appendices: addresses of standards organizations; addresses of registrars notified bodies; addresses of regulatory agencies; addresses of FDA offices; addresses of consulting training organizations; addresses of testing organizations. Glossary.

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