Regulatory Affairs for Biomaterials and Medical Devices

Stephen F. Amato,Robert M. Ezzell Jr

• Verlag: Woodhead Publishing
• Jahr: 2014
• ISBN:
  9780857099204
• Thema: Tecnología e ingeniería
• Thema: Ciencias biomédicas

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

Inhaltsverzeichnis

• Cover image
• Title page
• Table of Contents
• Copyright page
• List of contributors
• Woodhead Publishing Series in Biomaterials
• 1: Biomaterials and their applications in medicine
• 2: Technical considerations for commercialization of biomaterials
• 3: Regulatory strategies for biomaterials and medical devices in the USA: classification, design, and risk analysis
• 4: Clinical development and endpoint strategies for biomaterials and medical devices
• 5: The clinical evaluation and approval threshold of biomaterials and medical devices
• 6: Supply chain controls for biomaterials and medical devices in the USA
• 7: Global marketing authorisation of biomaterials and medical devices
• 8: Good manufacturing practice (GMP) for biomaterials and medical devices in the EU and the USA
• 9: Postmarket surveillance approaches for biomaterials and medical devices in the USA
• 10: Fundamentals of medical device approval in the Asia Pacific region
• Index