Medical Device Quality Assurance and Regulatory Compliance
Autor Richard C. Friesen Limba Engleză Paperback – 19 sep 2019
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| CRC Press – 19 sep 2019 | 481.05 lei 6-8 săpt. | |
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| CRC Press – 11 aug 1998 | 2039.69 lei 6-8 săpt. |
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Specificații
ISBN-13: 9780367400361
ISBN-10: 0367400367
Pagini: 496
Dimensiuni: 156 x 234 x 18 mm
Greutate: 0.45 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
ISBN-10: 0367400367
Pagini: 496
Dimensiuni: 156 x 234 x 18 mm
Greutate: 0.45 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
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Public țintă
Academic and Professional Practice & DevelopmentCuprins
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.
Descriere
"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."