A Device Master Record (DMR) is a collection of all the records that must be used to produce a medical device product.
Let’s imagine that your medical devices company is planning on manufacturing a new and improved coronary stent, which is a Class III medical device. You will need to record all the requisite information about the coronary stent including design requirements, specifications for production, quality assurance, packaging, labeling specifications, and others.
The collection of these records is referred to as the Device Master Record (DMR).
In this article, you will learn about Device Master Record (DMR) and its regulatory requirements, how it differs from DMR and DHR. We will also discuss the importance of organizing your DMR properly, and how to manage it effectively using QMS software.
Feel free to jump into the sections of interest:
- What Is Device Master Record (DMR)?
- What Is the Difference Between a DHF, DMR, and DHR?
- What Are the Requirements for Device Master Record?
- What Must the Device Master Record Include?
- Importance of Proper Device Master Record (DMR) Maintenance
- Software for Managing Medical Device Technical Documentation
What is Device Master Record (DMR)?
According to global regulatory agencies, your medical devices company must maintain all information and specifications related to the complete life cycle of every medical device produced. These centralized records are referred to as the Device Master Record (DMR) of that particular medical device.
The Device Master Record (DMR) contains appropriate drawings, material composition, specifications for the different components, the software required, quality assurance details, labeling, and packaging, as well as installation, maintenance, and servicing protocols.
What Is the Difference Between a DHF, DMR, and DHR?
You are likely to get confused between a Design History File (DHF), Device Master Record (DMR), and a Device History Record (DHR). However, while they are similar sounding, they are quite different in the purposes they serve. Each one is a cornerstone of the design control process.
Let us look briefly at each one to understand what their purpose is.
Design History File (DHF)
Design History File (DHF) is a repository of all records that will outline the design history of a given medical device.
Let us look at the example of the coronary stent that your company is manufacturing.
The DHF for the coronary stent will give the necessary evidence to regulatory agencies that all design control procedures about it have been properly applied and documented.
The DHF should contain:
- Design plan
- User requirement specifications
- Validation activities
- Component drawings
- Risk analysis
Device Master Record (DMR)
Device Master Record (DMR) will include all information needed for manufacturing the coronary stent.
In the case of our previously given example, Device Master Record (DMR) should contain the following details:
- Process and instrumentation diagrams
- Construction material details
- Component details
- Manufacturing details
- Packaging details
- Shelf-life of the coronary stent
Device History Record (DHR)
During the production of the coronary stent, you will maintain a Device History Record (DHR) that will demonstrate to regulatory agencies that all requirements of the DMR have been fulfilled.
Basically, the DHR is record-keeping and serves to track the production process of every lot or batch of the coronary stent.
The DHR will contain:
- Production records
- Quantity manufactured
- Quantity released for distribution
- Acceptance records
- Non-conformance reports
- The lot and serial number for every manufactured coronary stent
By using medical device QMS software it’s easy to maintain the structure of Design History File (DHF), Device Master Record (DMR), Device History Record (DHR). Furthermore, multiple documents and records can reside in multiple archives (DHF, DMR, DHR) at the same time without having to make duplicates of the same file.
What Are the Requirements for Device Master Record?
International regulatory agencies in the USA and the EU have specific requirements for the device master record to be maintained by your medical devices company.
FDA 21 CFR Part 820.181 states that:
“Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40.”
The ISO 13485:2016 standard combines all documentation, including DHF and DMR in a single file referred to as “Medical Device File” (see section 4.2.3).
What Must the Device Master Record Include?
According to the FDA 21 CFR Part 820.181, for example, as a coronary stent manufacturer, you must include the following details when you create a device master record for the coronary stent that you are manufacturing.
- Device specifications: These include appropriate drawings, composition, formulation, component specifications, and software specifications.
- Product process specifications: These include the appropriate equipment specifications required to manufacture the coronary stent, methods of production, the procedures used during production, and the environment in which the coronary stents are to be manufactured.
- Quality assurance procedures and specifications: These include acceptance and rejection criteria and the type of quality assurance equipment that will be used.
- Packaging and labeling specifications: These include the methods and processes to be used for packaging and labeling of the manufactured product.
- Installation, maintenance, and servicing protocols and methods.
- Bill of Materials (BOM): This term is used to describe the complete ‘Parts List’ of all components that are needed to complete a saleable coronary stent.
While maintaining this information, you must realize that the DMR is the place wherein you link to all other data stores. This means that you will not keep everything in the DMR itself.
Therefore, as you start preparing the DMR, you will understand that efficient QMS software becomes essential. This is because QMS software provides document control features such as document search, version control, access controls, linking, and many others. Without such a software solution, it will become extremely difficult to maintain up-to-date and well-organized device master records.
Importance of Proper Device Master Record (DMR) Maintenance
The chief intention of the device master record is to centralize all records of the production of any given medical device that your company manufactures.
Let’s revisit the example of the coronary stent that your company is manufacturing.
It consists of three components:
- A platform which is stainless steel or cobalt-chromium
- Active pharmacological drug agent
- Carrier vehicle
Let’s imagine that there has been a failure with the cobalt-chromium platform of the coronary stent and complaints are raised.
Your device master record for the aforementioned coronary stent is impeccably maintained in QMS software. So, you are immediately able to access all relevant manufacturing information, including dates, batch numbers, approvals, etc. This enables you to immediately analyze and identify the defective batch or lot and deploy CAPA to resolve the issue.
Here is an example of how the Device Master Record (DMR) for your coronary stent could be organized using QMS software like SimplerQMS:
- Declaration of conformity (DOC)
- Classification and intended use of the product
- Product specification and drawing specifications
- Essential requirements
- Risk management
- Basic specifications
- Product and process testing
- Sterility testing
- Shelf life
- Product flowchart and BOM
- Quality control instructions and forms
- Information on components
- Instruction of use (IFU) and labeling
- Clinical files
- Sales brochures
- Change requests after the product are released
- History of complaints
- CAPA history
- Literature on coronary stents
- Miscellaneous information
Software for Managing Medical Device Technical Documentation
International regulatory agencies such as the US FDA require that your device master record is compliant with FDA 21 CFR Part 820.181. This means that you must implement a robust document control system, with revision control, access controls, and other capabilities.
It is also important to maintain a central repository of all design controls used for the medical devices manufactured by your company.
Additionally, it’s worth remembering that the device master records will change and become more complex as time passes.
Looking at all these points, modern medical device QMS software with built-in document control features such as version control, access controls, electronic signatures, automated workflows, centralized repository, and others, become crucial for your medical device organization.
QMS software like SimplerQMS, allows you to store all your medical device documents and records in one place. You will be able to easily link design and development documentation to specific products and components. Seamlessly maintain the DHF, DMR, and TF for each medical device your company manufactures.
SimplerQMS helps you work most efficiently and save time and money, which are precious resources. Also, importantly, the software system helps you attain regulatory compliance with requirements applicable to medical device companies.
The device master record is a regulatory requirement for all medical device companies. It is a repository of all essential information about your company’s medical devices and includes design requirements, production requirements, quality assurance requirements, packaging and labeling specifications, and other records.
With efficient QMS software such as SimplerQMS, your work becomes so much easier and efficient. It will become easier to stay in compliance with all the mandated requirements, save time and money.
Ready to learn more about achieving efficiency in documentation processes in your medical device organization? Book a free demo today!