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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.
Stephen Amato is a member of the faculty teaching in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program at Northeastern University, Massachusetts. His research interests include U.S. and international product commercialization, FDA and global regulation, regulatory reimbursement, and the pricing of life sciences products. Bob Ezzell is a Graduate Instructor in Northeastern University's Regulatory Affairs Graduate Program, Massachusetts.
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
