PDA Combination Products Workshop 2011

The PDA 2011 Combination Products Workshop focuses on the device design validation requirements of FDA’s Quality System Regulation and the international harmonized quality standard ISO 13485:2003 which may be applied during the life-cycle of a combination product. The workshop will provide a discussion, review and interpretation of regulations and guidance applicable in the United States and Europe to the clinical evaluation of human factors, utilization of post-market data and risk management, functional stability and manufacturing as they relate to combination product design. It will include case studies and presentations by companies currently developing and managing the life-cycles of combination products. FDA representatives will discuss current expectations for combination products and will be available to answer your questions.