The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The guidance standard ISO/TR 14969 provides approaches to establish objectives, implement, monitor and measure the processes to improve performance. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. This package has a total savings of 30% off the list price and includes ISO 13485:2003 and ISO/TR 14969:2004.