Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards.

• Provides readers with a global perspective on medical device regulations
• Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards
• Includes a useful case study demonstrating the design and approval process

regulatory managers, companies that may not employ fulltime regulatory professionals; governmental regulators and manufacturers involved in global biomaterial, biomedical and life science product commercialization; students and graduates in healthcare, business administration and public health

• List of contributors