Erhältlich:
Nicht auf Lager
Buch (Softcover): Fachbuch
Medical Device Regulation
FDA-CDRH Manufacturing, Policies and Regulation Handbook
Produkt bewerten
Verlag:
Elsevier Unsere-Artikel-Nr.: L63N68D
EAN: 9780323953542
Erhältlich:
Nicht auf Lager
Zustellung: Di, 11.08.2026
Versand: Kostenlos
-22.3 %
CHF 260.–
CHF 202.–
Beschreibung
Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices.
Spezifikationen
Sprache
- Englisch
Autor
- Elijah Wreh
Zielgruppe
- Professional & Vocational
Erscheinungsjahr
- 2023
Format
- Buch (Softcover)
Anzahl Seiten
- 678