Medical Device Quality Assurance and Regulatory Compliance / Edition 1

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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.

The book contains black-and-white illustrations.

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Editorial Reviews

Intended for medical device manufacturers who need to know the basic concepts and issues of quality assurance and regulation, and strategies for compliance with requirements, so that they can integrate compliance into product development. Includes an overview of quality assurance and regulatory requirements, a detailed review of the ISO 9000 and ISO 14000 series of standards for quality systems, and an examination of standards specifically geared to medical devices. Also contains an analysis of the Medical Device Directives and the Quality System Regulations, and appendices listing standards organizations, Quality System registrars/Notified Bodies, regulatory agencies, FDA offices, consultants, and testing organizations. Annotation c. by Book News, Inc., Portland, Or.
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Product Details

  • ISBN-13: 9780824701772
  • Publisher: Taylor & Francis
  • Publication date: 8/11/1998
  • Edition description: ILLUSTRATE
  • Edition number: 1
  • 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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