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Medical Device Quality Assurance and Regulatory Compliance by Richard C. Fries at Abbey's Bookshop,
Medical Device Quality Assurance and Regulatory Compliance
— —
Richard C. Fries

Medical Device Quality Assurance and Regulatory Compliance

Richard C. Fries

$131

Paperback

Not in-store but you can order this
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English
CRC Press
19 September 2019
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:  
Imprint:   CRC Press
Country of Publication:   United Kingdom
Dimensions:   Height: 234mm,  Width: 156mm, 
Weight:   453g
ISBN:   9780367400361
ISBN 10:   0367400367
Pages:   496
Publication Date:  
Audience:   Professional and scholarly ,  Undergraduate
Format:   Paperback
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.

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