Medical Device Quality Assurance and Regulatory Compliance

Richard C. Fries

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Hardback

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English

CRC Press Inc
11 August 1998

Medical equipment & techniques; Precision instruments manufacture

"""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."""

By: Richard C. Fries
Imprint: CRC Press Inc
Country of Publication: United States
Dimensions: Height: 234mm, Width: 156mm, Spine: 29mm
Weight: 816g
ISBN: 9780824701772
ISBN 10: 0824701771
Pages: 496
Publication Date: 11 August 1998
Audience: College/higher education , Professional and scholarly , Further / Higher Education , Undergraduate
Format: Hardback
Publisher's Status: Active

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.

Fries, Richard C.