Medical Device Quality Assurance and Regulatory Compliance by Richard C. Fries (

Description: Medical Device Quality Assurance and Regulatory Compliance by Richard C. Fries "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." FORMAT Hardcover LANGUAGE English CONDITION Brand New Publisher Description "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." Author Biography Fries, Richard C. 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. Details ISBN0824701771 Author Richard C. Fries Short Title MEDICAL DEVICE QUALITY ASSURAN Language English ISBN-10 0824701771 ISBN-13 9780824701772 Media Book Format Hardcover Illustrations Yes Year 1998 Country of Publication United States Edition 1st Pages 496 Imprint CRC Press Inc Place of Publication Bosa Roca Affiliation Baxter Healthcare, Round Lake, Illinois, USA DOI 10.1604/9780824701772 UK Release Date 1998-08-11 AU Release Date 1998-08-11 NZ Release Date 1998-08-11 US Release Date 1998-08-11 Publisher Taylor & Francis Inc Publication Date 1998-08-11 Alternative 9780367400361 DEWEY 681.7610218 Audience Postgraduate, Research & Scholarly We've got this At The Nile, if you're looking for it, we've got it. With fast shipping, low prices, friendly service and well over a million items - you're bound to find what you want, at a price you'll love! TheNile_Item_ID:134447196;

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