Device Master File means a device reference source submitted to the FDA as defined by 21 CFR 814.3. Device Master File means the detailed information concerning the Product which is submitted to the relevant Governmental Authority and which is intended for incorporation into the Regulatory Dossier.
What is included in a device master record?
- Modern product records (e.g. ...
- Records are highly relational and include various associated data and files. ...
- Maintaining a system of spreadsheets and servers in a validated state is highly challenging. ...
What does master file mean?
The master file (MF) is a document which contains high level information about the global business operations and TP policy of an MNE group.
What is FDA device master file?
- An "MAF holder" is an organization or person filing an MAF.
- An "applicant" is an organization or person filing a PMA.
- A "sponsor" is an organization or person filing an IDE.
- An "agent or representative for an MAF holder" is a person or organization authorized to represent the MAF holder before FDA concerning the contents of the MAF.
What is the abbreviation for device master record?
Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device. It is further discussed in 21 CFR 820.3 (g) Design output. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and
What is the purpose of a device master record?
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.
What goes in a device master record?
A DEVICE MASTER RECORD (DMR) CONTAINS ALL OF THE INFORMATION AND SPECIFICATIONS NEEDED TO PRODUCE A MEDICAL DEVICE FROM START TO FINISH, INCLUDING INSTRUCTIONS FOR ALL MANUFACTURING PROCESSES, DRAWINGS, DOCUMENTED SPECIFICATIONS AND LABELING AND PACKAGING REQUIREMENTS.
What is the difference between a device master record and a device history record?
A DMR (Device Master Record) details the specific material, equipment, and environment requirements for production. The manufacturer maintains a DHR (Device History Record) which has all the documentation of the production process such as date produced, quantity, and labels of the final products.
What is DMR in engineering?
A Device Master Record (DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product. The term is used in Quality Management Systems that cover product design and production.
What is a medical device file?
Medical device files are documents that includes descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, levels of compliance with regulatory bodies and quality standards, and, if required, servicing and installation records and their ...
What is DMR in ISO?
A Device Master Record (DMR) is a document that contains the details necessary in order to build and test a device. DMR is mentioned in 21 CFR Part 820.40.
What is a master record index?
The Master Record Index – ILS (MRI-ILS) defines the standard of build of the Equipment. The index comprises a key to the approved drawings and associated records and lists all design changes introduced by amendments and modifications. The MRI-ILS is used by the Supplier to define the Equipment.
Is Bom part of DMR?
To communicate the component needs and cost estimates, an engineering project manager often creates an engineering BOM (EBOM) for the new product in a spreadsheet that also will become part of the device master record (DMR).
Is Process Validation part of DMR?
The FDA makes quite clear what is required to be placed in the DMR. The DMR should contain pointers (references) to: All relevant specifications, drawings, material compositions, formulations; Process specifications (i.e., process validation documents such as IQ, OQ, PQ, & PPQ);
What does a DMR typically contain?
What are the typical contents of a DMR? A Device Master Record for a medical device, typically includes the following documentation: Declaration of conformity (DOC) Intended use of the product.
Who is responsible for the DMR?
The permittee is responsible for completing the DMR form based on the lab results. and shall be submitted 30 days prior to transfer.
What is a DHR?
The FDA mandates that medical device companies produce a device history record (DHR) that contains all documentation related to manufacturing and tracking the device, and demonstrates that the device was manufactured according to the information in the device master record.
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.
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.
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.
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.
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.
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.
Final Thoughts
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.
What is a master record in medical device?
The device master record shall contain specifications of the device. When the medical device is a software, this means that the DMR shall reference the software requirement specifications as per ISO 62304. As mentioned before, the DMR shall also contain production process specifications.
What is a master record?
The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR 820.181. If we follow the definition reported in the regulation:
Why is document control important in medical device development?
In the world of medical device development and manufacturing, document control is critical to company success. Engineering records drive medical product development, and the company quality system and Standard Operating Procedures (SOPs) govern how business is conducted. Organized, revision-controlled, and auditable records are fundamental to maintaining regulatory compliance.
What is product record?
Product records are also shared with quality and compliance teams, and with purchasing and supply chain management for collaboration and review. In many cases, medical device companies use a system of servers, paper files, and spreadsheets to aggregate, share and control this data.
Can an ERP system be used to manage a DMR?
Spreadsheets and ERP systems do not have integral processes for managing engineering change orders (ECOs) and cannot be used to control device master record (DMR) changes, manage associated files or create proper documentation for the DHF.
What is a master file for devices?
What Are Master Files for Devices? Master Files for Devices (MAFs) are MFs that may be used to provide confidential, detailed information
What is a master file?
What Are Master Files? For CBER’s purposes, master files (MFs) are voluntary submissions of information to the FDA that may be used to provide confidential, detailed information to the FDA about the facilities, processes, or articles used in the manufacture, processing, packaging, or storing of one or more regulated products.
Managing DHF with Paper-based Quality Systems
If you’re using a paper-based QMS (quality management system) or “digital paper” approach, maintaining and compiling the DHF is going to be cumbersome. A DHF can take up several binders of physical documents with paper systems, or span hundreds of rows and columns across multiple Excel workbooks with digital paper solutions.
Managing DHF with Medical Device Quality Systems
A purpose-built QMS solution can save teams a considerable amount of time, serving as the guardrails to prevent mistakes from happening throughout the design and development process.
Difference Between DHF and DMR
The difference between the DHF and the DMR is in that first letter – design vs. device.
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Jesseca Lyons is a Senior Medical Device Guru at Greenlight Guru and a Mechanical Engineer by trade who loves working with cross functional teams, including both engineering and non-engineering disciplines. She’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry.
Medical Device File and Device Master Record
The contents of the MDF is very similar to the ones that should stay within the Device Master Record, that is a requirement according to 21 CFR 820. In fact, the section 21 CFR 820.181 specifies in details what the DMR shall include:
The contents of the Medical Device File according to ISO 13485
The requirements associated to MDF are mentioned in the section 4.2.3 of ISO 13485:2016. Specifically, for each medical device family, the organization shall document the so-called medical device file that shall contain the reference to all the documentation necessary to demonstrate compliance to the ISO 13485 and to all the applicable regulation.
Medical Device File Procedure
QualityMedDev has made available a medical device file procedure that describes the process related to construction of the medical device file. The procedure, specifically, contains the requirements for the medical device both according to ISO 13485:2016 and to EU MDR 2017/745.
Conclusions
In conclusions, we have been discussing the requirements associated to the Medical Device File with a reference to a specific procedure available at QualityMedDev DocShop that could be easily download.
