Medical Devices: Regulations, Standards and Practices: Woodhead Publishing Series in Biomaterials
Autor Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teoen Limba Engleză Hardback – 4 sep 2015
Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards.
- Provides readers with a global perspective on medical device regulations
- Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards
- Includes a useful case study demonstrating the design and approval process
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Specificații
ISBN-13: 9780081002896
ISBN-10: 0081002890
Pagini: 256
Dimensiuni: 152 x 229 x 18 mm
Greutate: 0.54 kg
Editura: ELSEVIER SCIENCE
Seria Woodhead Publishing Series in Biomaterials
ISBN-10: 0081002890
Pagini: 256
Dimensiuni: 152 x 229 x 18 mm
Greutate: 0.54 kg
Editura: ELSEVIER SCIENCE
Seria Woodhead Publishing Series in Biomaterials
Cuprins
1 Introduction
Part One
2 General regulations of medical devices
3 Quality management systems for medical device manufacture
4 The process of gaining approval for new medical devices
Part Two
5 Risk assessment and management for a new medical device
6 Safety testing of a new medical device
7 Clinical testing of a new medical device
8 Product development overview
Part Three
9 Case study: Successful development and approval of a new medical device
10 Global harmonization of medical devices
Part One
2 General regulations of medical devices
3 Quality management systems for medical device manufacture
4 The process of gaining approval for new medical devices
Part Two
5 Risk assessment and management for a new medical device
6 Safety testing of a new medical device
7 Clinical testing of a new medical device
8 Product development overview
Part Three
9 Case study: Successful development and approval of a new medical device
10 Global harmonization of medical devices