Device Master record

Description

Device Master Record (DMR)

A Device Master Record (DMR) is a vital document in the medical device manufacturing process. It includes all the instructions, processes, specifications, and information necessary to produce, test, and ensure the quality of a medical device. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), require the creation and maintenance of a DMR to ensure compliance with safety and efficacy standards.

Key Components of a Device Master Record

1. Device Specifications
   • Detailed design and manufacturing specifications.
   • Engineering drawings, component specifications, and software code (if applicable).
2. Production Process Specifications
   • Step-by-step procedures for manufacturing.
   • Equipment and tooling specifications.
   • Instructions for equipment setup, calibration, and operation.
3. Quality Assurance Procedures and Specifications
   • Quality control and testing procedures for various production stages.
   • Acceptance criteria for tests and inspections.
   • Environmental control and contamination prevention procedures, if needed.
4. Packaging and Labeling Specifications
   • Specifications to ensure proper packaging for storage and transport.
   • Labeling requirements, including content, format, and placement.
   • Instructions for any accompanying user manuals or documentation.
5. Installation, Maintenance, and Servicing Procedures
   • Instructions for installing, maintaining, and servicing the device, if applicable.
   • Recommended maintenance schedules and servicing procedures.

Importance of a Device Master Record

• Regulatory Compliance: Ensures the manufacturing process adheres to regulatory standards. Agencies like the FDA audit the DMR for compliance.
• Consistency and Quality: Ensures each device meets the same specifications, crucial for safety and efficacy.
• Traceability: Provides a history of the device’s production, important for post-market surveillance and recalls.
• Process Improvement: Helps identify areas for improvement and maintains process knowledge despite personnel changes.

Creating and Maintaining a Device Master Record

• Documentation: Includes written procedures, diagrams, photographs, and other relevant information.
• Regular Updates: Must be updated to reflect changes in design, materials, processes, or regulations.
• Training: Personnel involved in manufacturing and quality assurance should be trained to follow the DMR.

Regulatory References

• FDA: In the U.S., the FDA’s Quality System Regulation (21 CFR Part 820) specifies DMR requirements. Section 820.181 details the contents of the DMR.
• ISO 13485: This international standard for medical device quality management systems also requires detailed documentation of the manufacturing process, aligning with the DMR concept.