What is a DMR?
A Device Master Record (DMR) is a collection of documents and information that is used to describe the manufacturing and quality control of a medical device. It provides detailed information about the device, including its design, materials, production processes, testing procedures, etc., as per 21 CFR 820.181
What is the Importance of a DMR?
The DMR is an important part of a medical device Quality Management System (QMS) because it serves as a reference for the production and quality control of the device. It helps to ensure that the device is consistently manufactured and tested to meet the specified requirements and specifications of the FDA QSR as per 21 CFR 820.181. In addition, the DMR is used to demonstrate to Regulatory authorities that the device has been designed and manufactured in a controlled & systematic manner and meets the applicable Regulatory requirements. This will ensure that the device is safe and effective for its intended use.
What Information is Included in a DMR?
- 21 CFR 820.181 requires the device manufacturers to include the following information in DMRs:
- (a) Device specifications, including appropriate drawings, composition, formulation, component, and software specifications.
- (b) Production process specifications, including the appropriate equipment specifications, production methods, procedures, and environmental specifications.
- (c) Quality assurance procedures and specifications, including acceptance criteria and the quality assurance equipment to be used.
- (d) Packaging and labeling specifications, including methods and processes used.
- (e) Installation, maintenance, and servicing procedures and methods.
How is a DMR used in Practice?
A scenario where a DMR is used to troubleshoot a problem with a device or implement a design change is as follows:
- A customer reports a problem with a medical device, such as a malfunction or a failure. The manufacturer receives the complaint and begins an investigation to determine the root cause of the problem.
- The manufacturer references the DMR to review the design and development of the device, including information on the materials and components used, design specifications, and test results. This allows the manufacturer to identify potential issues with the design of the device that may have contributed to the problem.
- The manufacturer also uses the DMR to investigate for root cause/s of repetitive or recurring complaints.
- Based on the information in the DMR, the manufacturer determines that a design change is needed to address the problem. The manufacturer updates the DMR to reflect the design change, including a description of the change, the rationale for the change, and the results of any testing performed to evaluate the change.
- The manufacturer submits the updated DMR, along with a summary of the problem and the proposed design change, to the relevant Regulatory body for review and approval.
- Once the Regulatory body approves the design change, the manufacturer implements the change and begins manufacturing the device with the new design.
- The manufacturer also uses the updated DMR to ensure that the device meets Regulatory requirements and is safe and effective for its intended use.
Overall, DMR is an essential tool for manufacturers, Regulatory bodies, and other stakeholders to ensure that a medical device is developed and manufactured under Regulatory requirements and is safe and effective for its intended use.
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