A Device Master Record (DMR) is the collection of records containing the procedures and specifications for manufacturing a finished product used in quality management systems. The DMR includes the bill of materials, product and material specifications, design drafts, packaging and assembly instructions, any post-production cleaning and any hardware or software specifications and source codes.
What is the Device Master Record (DMR)?
The Device Master Record (DMR) is a comprehensive document that contains all the device specifications and instructions necessary for the production, labeling, packaging, and servicing of a medical device. It serves as a critical component of the quality management system (QMS) within medical device companies, ensuring compliance with regulatory requirements, facilitating traceability, and providing a complete record of the device's design process, design controls, production, and manufacturing processes.
The DMR is closely linked to the Design History File (DHF) and the Device History Record (DHR). While the DHF captures the design and development history of the device, and the DHR documents the specific details of each device unit produced, the DMR consolidates the information necessary for the successful manufacturing and servicing of the device.
The DMR contains detailed information about the device's specifications, including device design outputs, production process specifications, software specifications (if applicable), labeling specifications, and equipment specifications. These specifications ensure that the device is manufactured, labeled, and serviced consistently and in compliance with regulatory requirements.
Manufacturing processes are documented in the DMR, describing the steps, methods, and procedures necessary for producing the device. This includes formulation, assembly, testing, and any necessary sterilization processes. The DMR provides clear instructions and guidelines to ensure that the device is produced consistently, meeting the required quality and performance standards.
Labeling requirements are an essential part of the DMR. It specifies the information that must be included on the device's label, such as its intended use, warnings, precautions, and any regulatory symbols or markings. The DMR ensures that the labeling complies with applicable regulatory requirements and facilitates proper identification and traceability of the device.
The DMR also encompasses information related to document control, acceptance criteria, and quality assurance procedures. It outlines the procedures for document control to ensure that the DMR is current, accurate, and accessible to authorized personnel. Acceptance criteria are defined to establish the standards that the finished device must meet in order to be considered acceptable for release. Quality assurance procedures are included to ensure that the device is manufactured consistently and meets the specified requirements throughout its life cycle.
Risk management plays a crucial role in the DMR. It involves identifying potential risks associated with the device's design, manufacturing, and servicing processes. Risk management strategies and mitigation measures are documented within the DMR to address and minimize potential risks throughout the device's life cycle.
Regulatory compliance is a key consideration in the development and maintenance of the DMR. The DMR aligns with regulatory requirements set forth by bodies such as ISO 9000 and the Food and Drug Administration (FDA) in the United States, particularly in relation to FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR). Compliance with FDA regulations ensures that the device is produced in accordance with quality standards and regulatory guidelines.
To support organizations in understanding and implementing the DMR effectively, resources such as webinars, training materials, and guidance documents are available. These resources provide insights into best practices, regulatory expectations, and documentation requirements related to the DMR, assisting medical device companies in developing and maintaining compliant and comprehensive device master records.
In summary, the Device Master Record (DMR) is a crucial document within the quality management system (QMS) of medical device companies. It consolidates all the necessary specifications, instructions, and records required for the production methods, labeling, packaging, and servicing of a medical device. The DMR ensures compliance with regulatory requirements, facilitates traceability, and provides a complete and comprehensive record of the device's manufacturing and production processes.