"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."
"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."Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
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.
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.
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