Device Master Record (DMR)

A Device Master Record (DMR) is a comprehensive compilation of documents that outlines the specifications, production processes, quality assurance measures, and labeling requirements for a 医疗器械. It serves as a critical reference for ensuring compliance with regulatory standards and maintaining consistency throughout the manufacturing process. The DMR is essential for facilitating effective 沟通 among design, engineering, and production teams, ultimately supporting the successful development and commercialization of the device.