Regulatory Affairs for Biomaterials and Medical Devices

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. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices
- Especially useful for smaller companies who may not employ a full time vigilance professional
- Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

1. Biomaterials and their applications in medicineI. Kulinets, Northeastern University, USA2. Technical considerations for the commercialization of biomaterialsN. Scarborough, NLS Consulting, USA and N. Mukherjee, Covidien, USA 3. Regulatory strategies for biomaterials and medical devices in the USA: Classification, design and risk analysisS. F. Amato, Northeastern University, USA4. Clinical development and endpoint strategies for biomaterials and medical devicesS. F. Amato, Northeastern University, USA5. The clinical evaluation and approval threshold of biomaterials and medical devicesK. G. Stevens, DePuy Synthes Spine, USA6. Supply chain controls for biomaterials and medical devices in the USAS. F. Amato, Northeastern University, USA7. Global marketing authorisation of biomaterials and medical devicesJ. J. Tobin, ChemHaz Solutions, Ireland8. Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USAF. Tarabah, Strategiqual, France9. Post market surveillance approaches for biomaterials and medical devices in the USAK. Desai, Northeastern University, USA10. Fundamentals of medical device approval in AsiaJ. L. Wong, ARPA, Hong Kong and P. Teysseyre, Johnson & Johnson Medical Asia Pacific, Singapore