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 authorsa 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 processFor certain types of devices, companies must have their quality management system certified to ISO 13485 to legally sell or ... Template documentation of a quality manual that meets the requirements of ISO 13485 can be accessed online atanbsp;...
|Author||:||Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo|
|Publisher||:||Woodhead Publishing - 2015-08-18|