Neuware - 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.

N� de ref. del art�culo 9780323953542

Contactar al vendedor

Denunciar este art�culo

Detalles bibliogr�ficos

T�tulo: Medical Device Regulation : FDA-CDRH Manufacturing, Policies and Regulation Handbook
Editor: Elsevier Science & Technology Feb 2023
Fecha de publicaci�n: 2023
Idioma: Ingl�s
ISBN 10: 0323953549
ISBN 13: 9780323953542
Encuadernaci�n: Taschenbuch
Estado: Neu
Dimensiones: 235�mil�metros de ancho por 190 de alto por 38 de largo
Peso: 1338 gramos

Acerca de

Sinopsis

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.

Acerca del autor

Elijah Wreh is an accomplished regulatory affairs leader with a proven track record of success in the medical device industry. Comprehensive experience bringing medical devices to market from viability through design, verification, and validation to global regulatory approvals. Highly proficient at streamlining procedures, implementing best practices, and pulling a talented group of professionals together into a high-performing team. He is an adjunct professor at Case Western Reserve University and the University of Akron, a part-time lecturer at Northeastern University – College of Professional Studies, and a guest lecturer at Cleveland State University. Mr. Wreh’s lecture on regulatory aspects of the medical device product commercialization lifecycle from the United States (US); international perspectives, and provisions of the US Food and Drug Administration’s (FDA’s) risk-based medical device classification scheme, such as the Premarket Notification [(510(k)], Premarket approval (PMA), and Investigational Device Exemption (IDE) submission processes. He is also an Industry Representative for the FDA Neurological Devices Advisory Committee Panel and Vice Chairman of the Board of Directors of CommStar Credit Union.

He holds a Master of Arts in Christian Ministry from Liberty University, a Master of Science in Regulatory Science from the University of St. Thomas, and a Bachelor of Science in Human Biology from Minnesota State University. A certificate in Healthcare Compliance from Seton Hall Law School and a Risk Analysis certificate from Harvard T.H. Chan School of Public Health.

"Sobre este t�tulo" puede pertenecer a otra edici�n de este libro.

Descripci�n de la librer�a

Das Unternehmen AHA-BUCH GmbH: Seit der Gr�ndung von AHA-BUCH im Juli 2005 ist unser Hauptziel, zufriedenen Kunden so schnell und so preisg�nstig wie m�glich ihren B�cherwunsch zu erf�llen. Unsere Firma besch�ftigt 16 Mitarbeiter, die nur ein Ziel kennen: den Kunden und seine W�nsche! Auf �ber 3700 m2 Fl�che haben wir �ber 100.000 B�cher, Modernes Antiquariat und Spiele auf Lager.

Ver la p�gina web de la librer�a

Informaci�n empresarial del vendedor

AHA-BUCH GmbH
Garlebsen 48, Einbeck, 37574, Germany

Condiciones de venta y env�o

Condiciones de venta

T�rminos y Condiciones Generales e Informaci�n del Cliente / Pol�tica de Privacidad

I. T�rminos y Condiciones Generales

� 1 Disposiciones b�sicas

(1)Los siguientes t�rminos y condiciones se aplican a todos los contratos que celebre con nosotros como proveedor (AHA-BUCH GmbH) a trav�s de las plataformas de Internet AbeBooks y/o ZVAB. A menos que se acuerde lo contrario, se objetar� la inclusi�n de cualquiera de sus propios t�rminos y condiciones utilizados por usted.
(2)Un consumidor en el sentid...

M�s informaci�n

Derecho a cancelaci�n

Condiciones de env�o

Enviamos su pedido despu�s de recibirlos
para art�culos disponibles las �ltimas 24 horas,
para art�culos con suministro nocturno a m�s tardar 48 horas.
En caso de que necesitemos pedir un art�culo a nuestro proveedor, nuestro tiempo de env�o depende de la fecha de recepci�n de los art�culos, pero los art�culos se enviar�n el mismo d�a.

Nuestro objetivo es enviar los art�culos pedidos de la manera m�s r�pida, pero tambi�n m�s eficiente y segura a nuestros clientes.

Tarifas de env�o de Alemania a Estados Unidos de America

Tarifas de env�o de Alemania a Estados Unidos de America
Cantidad del pedido	De 30 a 40 d�as h�biles	De 7 a 14 d�as h�biles
Primer art�culo	EUR 66.69	EUR 76.69

Los plazos de entrega los establecen los vendedores y var�an seg�n el transportista y la ubicaci�n. Los pedidos que pasan por la aduana pueden sufrir retrasos y los compradores son responsables de los aranceles o tarifas asociadas. Los vendedores pueden ponerse en contacto con usted en relaci�n con cargos adicionales para cubrir cualquier aumento en los costes de env�o de los art�culos.

Informaci�n detallada sobre el vendedor