Richard C Fries

Medical Device Quality Assurance and Regulatory Compliance

• Broschiertes Buch

Produktbeschreibung

"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."

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Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 496
• Erscheinungstermin: 19. September 2019
• Englisch
• Abmessung: 231mm x 155mm x 18mm
• Gewicht: 590g
• ISBN-13: 9780367400361
• ISBN-10: 0367400367
• Artikelnr.: 57814939

Autorenporträt

Fries, Richard C.

Inhaltsangabe

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.