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Medical Devices
Regulations, Standards and Practices
A useful step-by-step guide on designing medical devices to ensure regulatory approval
Seeram Ramakrishna (Author), Lingling Tian (Author), Charlene Wang (Author), Susan Liao (Author), Wee Eong Teo (Author)
9780081002896, Elsevier Science
Hardback, published 5 September 2015
256 pages
22.9 x 15.1 x 2.1 cm, 0.42 kg
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. 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.
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
Subject Areas: Biomedical engineering [MQW], Medical equipment & techniques [MBG]
