A robust quality management system is an extremely crucial aspect for maintaining the safety, compliance, and quality of a medical device. Within this system, every process, from design to delivery, follows a structured process.
Device Master Record is a type of structured documentation process that encapsulates all details such as materials, equipment, specifications, assembly instructions, testing methods, and labeling guidelines to manufacture a medical device as per the specifications. In this article, we discuss the Device master record in medical device development, its best practices, components, and significance, in detail.
What is a Device Master Record?
DMR, abbreviated as the Device Master Record is a centralized system of a comprehensive compilation of all the documentation required to manufacture a medical device. It includes the approved specifications for the completed medical device, and a detailed description of processes, components, software, etc.
It is a crucial regulatory requirement by the US FDA, under 21 CFR Part 820. The DMR is specific to FDA regulations. A similar concept of Medical Device File is required by ISO 13485:2016, which serves a comparable purpose by detailing the requirements for the production and control of medical devices.
Medical device manufacturers maintain and own the DMR. Developing a robust DMR not only facilitates regulatory compliance but also safety and efficacy. A thorough and well-managed DMR benefits every stakeholder.
Device Master Record Documentation
DMR Goals in Medical Device Production
Maintaining documentation is a crucial aspect of medical device production, management, and regulatory compliance. FDA’s 21 CFR 820 regulates the medical device quality systems and indicates five record types that the medical device manufacturers must maintain. These record types are listed below:
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
- Quality System Record (QSR)
- Complaint Files
Each of these record types has a distinct purpose. The primary goal of DMR documentation in medical device production is to organize all the relevant and required documentation of a specific medical device. The main aim of the device master record in medical device production is to ensure that the manufacturing process is accurately defined and standardized.
DMR Documentation Requirement
A device master record is a key aspect of regulatory compliance, which is why medical device manufacturers maintain it to be FDA-compliant. The DMR is an FDA specific requirement, which is why, if you don’t need to get a FDA approval for your medical device, you may not need a DMR. On the other hand, if you market your medical device in the US, it will require FDA approval. The FDA reviews the DMR during audit, which is why DMR is essential for regulatory audit processes.
Device Master Record Implementation Advantages
The DMR is crucial for both regulatory compliance and product quality. Let’s understand the implementation advantages of the Device Master Record:
Product Quality
DMR implementation ensures product quality and consistency. It ensures that every medical device meets the expected specifications.
Standardized Manufacturing Processes
Device Master Record implementation defines every manufacturing process. Standardization of manufacturing processes reduces variations and leads to predictable outcomes. It furthermore reduces manufacturing errors and improves overall efficiency. DMR offers clear and detailed instructions which further, prevent misinterpretations.
Training Facilitation
DMR documentation facilitates training and creates a structured training program. Device Master Record enables trainees and employees to learn the medical device manufacturing processes and understand the quality expectations.
Traceability and Accountability
Device Master Record enhances traceability and accounting as it links product design to manufacturing.
Supply Chain Management Improvement
The Device Master Record Documentation improves supply chain management. It clearly enlists the material specifications, and enables medical device manufacturers to identify reliable suppliers. This helps to strengthen the supply chain and improve its management.
Device Master Record Documentation Best Practices
Standardized Templates
The first best practice is to incorporate standardized templates to improve and ensure consistency across DMRs. The incorporation of standardized templates also avoids formatting errors.
Establish Revision History
Revision history enables medical device manufacturers to track changes over time. Manufacturers must clearly label each DMR-related document with authorship, dates, and version numbers.
Maintain Correct Versions
The next DMR documentation best practice is to maintain correct versions of the device master record. In order to do so, you should include revision history, label each version, and archive older versions for future audits.
Procedure Validation
Manufacturers must validate each process before including it in the DMR documentation. You should note to include the test data of the process to support the validation.
Staff Training
The next best practice is to conduct regular staff training to ensure that they understand and update the DMR. You should note to update the training logs.
Incorporate Electronic Signatures
Electronic signatures reduce forgery risk. You must however; ensure that the e-signature system is in compliance with FDA’s 21 CFR Part 11.
Schedule Periodic Reviews
The next best practice is to schedule periodic reviews. You should note to regularly review and update the DMR content to ensure compliance. In addition, periodic DMR reviews ascertain its completeness and accuracy.
Automated Systems
There are various challenges with manual systems. Automated quality and information management systems are extremely advantageous in efficient DMR management.
Role of QMS Software in DMR Management
Manual DMR Management can pose significant challenges as paper-based systems are difficult to maintain and often prone to errors. QMS software resolves such concerns.
A QMS software implementation for DMR management minimizes manual errors, maintains up-to-date records, and simplifies audits. Let’s understand the role of QMS software in DMR Management:
Centralized Document Control
A QMS software ensures that all the DMR-related documents are streamlined and centralized. You should note that it creates a single repository. This ensures that QMS software secures and centralizes all DMR documents.
Easy DMR Document Access
QMS software enables medical device manufacturers to locate DMR-related documents through search functions. It eliminates manual search, which saves valuable time. It also links documents to maintain connections between records.
Version Control
QMS software enables medical device manufacturers to manage document versions. It retains previous iterations and tracks changes. This ensures that everyone in the DMR-related document management is working upon the current version and not on an out-dated version.
Data Security
A QMS software enables controlled distribution to authorized personnel. It employs encryption to ensure that only authorized personnel are able to access and modify the documents. Such a controlled environment maintains security and data integrity.
Supports Regulatory Compliance
A major role of QMS software in DMR management is that it supports regulatory compliance with FDA 21 CFR Part 820 and ISO 13485:2016. It enables medical device manufacturers to perform audit trails for tracking modifications and unique identification tags for traceability. All of these capabilities support stringent document control and management to align with FDA 21 CFR Part 820 and ISO 13485 requirements.
Audit Readiness
It enables medical device manufacturers to build a robust compliance framework as it prepares companies for audits. Since the QMS software records every action, it creates a comprehensive audit trail thus ensuring that the medical device management proves compliance, simplifying regulatory inspections.
Pipette Tips Manufacturing
QMS software can map regulatory requirements. It enables medical device manufacturers to link DMR elements to regulations. It also helps to identify gaps, thereby aiding in regulatory mapping and ensuring compliance.
Automated Review and Approval
The next role of QMS software is to review and manage document approval workflows. This further ensures timely sign-offs, and maintains clear audit trails.
Automated Notifications
The QMS system facilitates efficiency by sending automated notifications and alerts to stakeholders. It informs them about the changes, pending tasks thereby, ensuring timely actions.
DMR Versus DHF and DHR
Device Master Record (DMR), Design History File (DHF), and Device History Record (DHR) are crucial aspects of medical device documentation that the US FDA requires. Each of these serves a distinct purpose.
DMR comprises all the necessary information to manufacture a medical device according to the specifications. DHF, on the other hand, focuses on documenting the history of the design and development of a medical device, and DHR focuses on the production history of the medical device.
Manufacturers develop DHR and DHF based on DMR content. Device Master Record consists of more information than the design of a new medical device. It defines necessary manufacturing parameters, and design controls, design verification, and validation activities.
DMR Documentation
The FDA mandates specific documentation for DMR requirements. Let’s understand these details further in this section.
FDA DMR Requirements
Device Master Record – 21 CFR Part 820
The FDA’s 21 CFR Part 820 Subpart M outlines DMR requirements. It details design, production, and process controls. It also enlists that the DMR is prepared and approved as per section 820.40. You can read more about it here.
Design Controls – 21 CFR 820.30
The design controls are regulated as per the 21 CFR 820.30 section. It ensures correct medical device design. You can read more about it here.
Production and Process Controls – 21 CFR 820.70
The FDA regulates production and process controls under 21 CFR 820.70 Subpart G section. They govern manufacturing processes. You can read more about it here.
Device Master Record Components
The Device Master Record is a centralized file that includes all the specifications for the medical device. It ensures consistency in production such that every medical device is manufactured as per the expected specifications. A DMR contains several components and manufacturers must ensure that each DMR complies with FDA CFR Part 820. Let’s understand these key elements further:
Device Specifications
The first key DMR component is the device specifications. In these components, medical device manufacturers define the product, outline its design and detail performance criteria. Medical device manufacturers clearly set these expectations to ensure the device functions as intended. The device specifications include approved drawings, schematic diagrams, components, and software specifications.
Manufacturing Processes
The next DMR component is the manufacturing processes and procedures. This particular Device Master Record component ensures consistent production and minimizes human error. It describes processing procedures and enlists details of every production step. It also includes equipment, production environment, sterilization method specifications, and outlines assembly instructions.
Quality Control Procedures
This DMR component details the quality control processes and procedures. It enlists the inspection criteria to ensure that all the functional and safety specifications of the medical device are as per the requested standards. This DMR component verifies product quality and ensures compliance with the regulatory standards.
Labeling and Packaging Specifications
The next DMR component includes outlining the labelling and packaging specification. Let’s understand these specifications further:
- The labeling specification defines the format and outlines the content. It includes component specifications and formulations.
- The packaging specifications list the materials and methods to ensure safe packaging.
Installation, Maintenance, and Servicing Procedures
Correct installation and regular maintenance of the medical device ensure functionality. These procedures include an exhaustive list of materials and parts. In addition, it also explains device setup, routine care, and repair processes in detail.
References and Linked Files
This section includes references to external files or repositories. It links the DMR to relevant records, documents, or databases that are from other parts of the quality management system.
Contact Us
DMR documentation plays a key role in maintaining product consistency and safety. It ensures that medical device manufacturers employ the same process to replicate quality. It also enables manufacturers to meet several critical regulatory and quality standards.
At VEM-Tooling and VEM-Medical, we have a team of design experts and engineers with over 20 years of experience that can guide you with DMR documentation and other QMS solutions. We have been stringently applying QMS for our OEMs. You can view our certificates here.
