Regulatory Affairs Certification (RAC) 2025 – 400 Free Practice Questions to Pass the Exam

The Device Master Record (DMR) is a comprehensive collection of documents that provide the necessary information for the production of a medical device. It includes specifications for the device, production processes, quality assurance, and more, which are essential for ensuring that the device complies with regulatory requirements and meets quality standards.

The reason that employee training records are not included in the Device Master Record is that the DMR primarily focuses on the technical and procedural aspects of the device itself rather than the personnel involved in its production. While employee training is an important element of a quality management system, it is typically documented separately within the quality system records. This ensures that personnel compliance with training requirements is tracked independently of the product specifications and manufacturing procedures.

In contrast, serial number labels, design reviews, and calibration records are integral parts of the DMR. Serial number labels serve to identify and trace the devices, design reviews ensure that the development meets its intended requirements and regulatory standards, and calibration records document the verification of equipment used in the manufacturing process. Each of these elements is crucial to the integrity and traceability of the device, making them essential components of the Device Master Record.