Medical Device Quality Assurance and Regulatory Compliance
Crc Press Inc (Verlag)
978-0-8247-0177-2 (ISBN)
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.
| Erscheint lt. Verlag | 11.8.1998 |
|---|---|
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 156 x 234 mm |
| Gewicht | 816 g |
| Themenwelt | Medizin / Pharmazie |
| Technik ► Medizintechnik | |
| ISBN-10 | 0-8247-0177-1 / 0824701771 |
| ISBN-13 | 978-0-8247-0177-2 / 9780824701772 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
aus dem Bereich
