Manufacture Your Product

Device Master Record (DMR): The Blueprint for Consistent, Compliant Medical Device Manufacturing

The Device Master Record (DMR) is a comprehensive blueprint containing all the essential information required to manufacture a medical device consistently and in compliance with regulatory standards. It ensures every device produced meets the same high standards of quality, safety, and performance.

A well-constructed DMR typically includes:

• Design Specifications: Detailed descriptions, technical drawings, dimensions, materials, and components of the device.
• Production Process Specifications: Step-by-step manufacturing instructions, including tools, machinery, and environmental conditions required for production.
• Quality Assurance Procedures: Inspection, testing, and validation protocols to ensure compliance with predefined quality and safety standards.
• Packaging and Labeling Specifications: Clear requirements for device packaging and labeling to guarantee proper identification and regulatory alignment.
• Maintenance and Servicing Procedures: Detailed guidelines for the ongoing maintenance, repair, and servicing of the device to ensure continued performance and safety.

The DMR is not just a regulatory requirement—it’s a cornerstone of your manufacturing process, acting as a reference point for audits, regulatory submissions, and continuous improvement. At RQMIS, we help you develop and optimize your Device Master Record, ensuring it serves as a robust foundation for reliable, scalable, and compliant device production.

Master Manufacturing Record (MMR): Ensuring Consistent Quality and Regulatory Compliance in Every Batch

The Master Manufacturing Record (MMR) is a detailed document that serves as the blueprint for the consistent production of medical products, ensuring that each batch or lot adheres to predetermined specifications, quality standards, and regulatory requirements.

A robust MMR typically includes:

• Batch Formula: Precise details of ingredients, raw materials, and their specific quantities required for each batch.
• Manufacturing Instructions: Step-by-step procedures outlining the manufacturing process, including equipment, processing conditions, and critical control points.
• Quality Control Procedures: Defined protocols for testing, inspections, and validations performed during and after manufacturing to ensure compliance with quality standards.
• Packaging Instructions: Guidelines specifying how the product should be packaged, labeled, and sealed to ensure protection, traceability, and regulatory alignment.
• Record Keeping: Comprehensive documentation for every batch, including production dates, batch numbers, quantities, test results, and records of any deviations from standard processes.

The MMR is not merely a compliance requirement—it’s the cornerstone of consistent manufacturing excellence. It provides a clear, repeatable framework for production teams, quality assurance personnel, and regulatory auditors.

Maintaining a State of Control: Ensuring Compliance with FDA GMPs and ISO Standards Through Robust Auditing and Oversight

Operating in a state of control means consistently producing your product according to FDA Good Manufacturing Practices (GMPs) and ISO standards, ensuring product quality, safety, and regulatory compliance at every stage of the manufacturing process.

To achieve and maintain this state:

• Internal Audits: Regular, systematic internal audits are essential to evaluate your processes, identify areas for improvement, and ensure ongoing compliance with GMPs and ISO standards. These audits help detect and address deviations before they become regulatory issues.
• Documentation and Traceability: Comprehensive documentation must be maintained to demonstrate adherence to established processes, ensuring complete traceability of raw materials, production steps, and quality checks.
• Continuous Improvement: Findings from internal audits should feed into a continuous improvement cycle, refining manufacturing processes and enhancing operational efficiency.
• 3rd-Party Demonstration: You must be prepared to demonstrate compliance to external parties, such as the FDA during inspections and Notified Bodies during ISO certification audits. Clear records, robust quality management systems, and employee training programs are critical in these evaluations.

At RQMIS, we guide you in developing a thorough and compliant DMR/MMR, ensuring your product meets regulatory standards while supporting consistent manufacturing outcomes. This foundational document is not just a regulatory requirement—it's a key asset for scaling production, maintaining quality, and ensuring patient safety.