Description

The Device Master Record (DMR) Template is a key document used in compliance with ISO 13485, an international standard for quality management systems in the medical device industry. This template serves as a comprehensive repository for all essential information related to the design, manufacturing, and quality control of a medical device. It includes specifications, drawings, procedures, and other relevant documents necessary for the production of the device. The DMR Template ensures that all aspects of the device’s manufacturing process are clearly defined, controlled, and documented, helping to maintain consistency, traceability, and compliance with regulatory requirements. By using the DMR Template, medical device manufacturers can effectively manage their product information and demonstrate conformity with ISO 13485 standards, ultimately contributing to the safety and efficacy of their devices.