Regulatory Affairs for Biomaterials and Medical Devices

This 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.

Stephen F. Amato (Edited by), Robert M. Ezzell Jr (Edited by)

9780857095428, Elsevier Science

Hardback, published 16 October 2014

202 pages
22.9 x 15.1 x 2 cm, 0.44 kg

All 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.

1. Biomaterials and their applications in medicine I. Kulinets, Northeastern University, USA 2. Technical considerations for the commercialization of biomaterials N. Scarborough, NLS Consulting, USA and N. Mukherjee, Covidien, USA 3. Regulatory strategies for biomaterials and medical devices in the USA: Classification, design and risk analysis S. F. Amato, Northeastern University, USA 4. Clinical development and endpoint strategies for biomaterials and medical devices S. F. Amato, Northeastern University, USA 5. The clinical evaluation and approval threshold of biomaterials and medical devices K. G. Stevens, DePuy Synthes Spine, USA 6. Supply chain controls for biomaterials and medical devices in the USA S. F. Amato, Northeastern University, USA 7. Global marketing authorisation of biomaterials and medical devices J. J. Tobin, ChemHaz Solutions, Ireland 8. Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USA F. Tarabah, Strategiqual, France 9. Post market surveillance approaches for biomaterials and medical devices in the USA K. Desai, Northeastern University, USA 10. Fundamentals of medical device approval in Asia J. L. Wong, ARPA, Hong Kong and P. Teysseyre, Johnson & Johnson Medical Asia Pacific, Singapore

Subject Areas: Medical equipment & techniques [MBG]