Medical Device Quality Assurance and Regulatory Compliance

Richard C. Fries (Autor)

Buch | Softcover

496 Seiten

2019
CRC Press (Verlag)
978-0-367-40036-1 (ISBN)

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"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."

Fries, Richard C.

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.

Erscheinungsdatum	24.09.2019
Verlagsort	London
Sprache	englisch
Maße	156 x 234 mm
Gewicht	453 g
Themenwelt	Schulbuch / Wörterbuch
	Medizin / Pharmazie ► Physiotherapie / Ergotherapie ► Orthopädie
	Technik ► Medizintechnik
	Technik ► Umwelttechnik / Biotechnologie
ISBN-10	0-367-40036-7 / 0367400367
ISBN-13	978-0-367-40036-1 / 9780367400361
Zustand	Neuware