Safety Evaluation in the Development of Medical Devices and C... - 9781420071641

CRC Press

Safety Evaluation in the Development of Medical Devices and Combination ProductsAuthor(s): Shayne C. Gad, Marian G. McCord\nFormat: Hardback\nPublisher: Taylor & Francis Inc, United States\nImprint: CRC Press Inc\nISBN-13: 9781420071641, 978-1420071641\nSynopsis\nCapturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.\n\nThe Third Edition explores these key current trends:\n\nglobal device markets\ncontinually advancing technology\nthe increasing harmonization of device safety regulation worldwide\n\nEach aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and .