{"product_id":"regulatory-affairs-for-biomaterials-and-medical-devices-hardback-9780857095428","title":"Regulatory Affairs for Biomaterials and Medical Devices (Hardback) 9780857095428","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eRegulatory Affairs for Biomaterials and Medical Devices\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cem\u003eThis book provides key information on the regulatory practices and policies relating to biomaterials and medical devices in different regions, particularly Europe, the USA and Asia.\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eStephen F. Amato (Edited by), Robert M. Ezzell Jr (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780857095428, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 16 October 2014\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e202 pages\u003cbr\u003e22.9 x 15.1 x 2 cm, 0.44 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003eAll biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e1. Biomaterials and their applications in medicine \u003ci\u003eI. Kulinets, Northeastern University, USA \u003c\/i\u003e2. Technical considerations for the commercialization of biomaterials \u003ci\u003eN. Scarborough, NLS Consulting, USA and N. Mukherjee, Covidien, USA  \u003c\/i\u003e3. Regulatory strategies for biomaterials and medical devices in the USA: Classification, design and risk analysis \u003ci\u003eS. F. Amato, Northeastern University, USA \u003c\/i\u003e4. Clinical development and endpoint strategies for biomaterials and medical devices \u003ci\u003eS. F. Amato, Northeastern University, USA \u003c\/i\u003e5. The clinical evaluation and approval threshold of biomaterials and medical devices \u003ci\u003eK. G. Stevens, DePuy Synthes Spine, USA \u003c\/i\u003e6. Supply chain controls for biomaterials and medical devices in the USA \u003ci\u003eS. F. Amato, Northeastern University, USA \u003c\/i\u003e7. Global marketing authorisation of biomaterials and medical devices \u003ci\u003eJ. J. Tobin, ChemHaz Solutions, Ireland \u003c\/i\u003e8. Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USA \u003ci\u003eF. Tarabah, Strategiqual, France \u003c\/i\u003e9. Post market surveillance approaches for biomaterials and medical devices in the USA \u003ci\u003eK. Desai, Northeastern University, USA \u003c\/i\u003e10. Fundamentals of medical device approval in Asia \u003ci\u003eJ. L. Wong, ARPA, Hong Kong and P. Teysseyre, Johnson \u0026amp; Johnson Medical Asia Pacific, Singapore\u003c\/i\u003e\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Medical equipment \u0026amp; techniques [\u003ca title=\"See our other books on Medical equipment \u0026amp; techniques\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Medical%20equipment%20\u0026amp;%20techniques%20%5BMBG%5D%22\"\u003eMBG\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Woodhead Publishing","offers":[{"title":"Default Title","offer_id":46651633631512,"sku":"9780857095428","price":98.99,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9780857095428_0cf64eec-dde4-4102-96db-7ad3e549c76c.jpg?v=1696781720","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/regulatory-affairs-for-biomaterials-and-medical-devices-hardback-9780857095428","provider":"Freshly Printed Books","version":"1.0","type":"link"}