[Download] ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control (English Edition) de Brendan Cooper Ebooks, PDF, ePub, ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control (English Edition) Pdf libro
ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control (English Edition) de Brendan Cooper
Descripción - This concise book is broadly divided into 3 parts. The first part introduces the standard ISO 13485 and Quality management systems. Part two then examines the key area of Design controls and there application to medical devices. Finally, a review of Quality Risk management is provided. In the first instance, providing safe and effective medical devices depends on a sound basis’ of design. However, how we see and rate risks also impacts the safety of products produced. A holistic approach to medical device manufacturing ensures Quality from design conception to commercial manufacturing. Following the principles within this short book will put the reader on the right track. An ideal reference for industry or academics.
Detalles del Libro
- Name: ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control (English Edition)
- Autor: Brendan Cooper
- Categoria: Libros,Libros universitarios y de estudios superiores,Medicina y ciencias de la salud
- Tamaño del archivo: 8 MB
- Tipos de archivo: PDF Document
- Descargada: 637 times
- Idioma: Español
- Archivos de estado: AVAILABLE
Descargar Ebook ISO 13485 - the Quality Management System for Medical Devices: Understanding Quality, Risk and Design Control (English Edition) de Brendan Cooper PDF [ePub Mobi] Gratis
MD Guidance Documents (1) / Medical Device / Quality ~ Alternative QMS are: i) a full QMS including design control; or ii) a production QMS excluding design control both based on ISO 13485 but with exclusions for ii). 5.4.5 The RA or CAB may determine whether the quality management system has been effectively implemented and maintained by i) for Class A devices, reviewing a self-declaration .
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