Design history file device master record device history record. The food and drug administration fda requires manufacturers of medical devices to create and maintain a device master record dmr. A design history file is a compilation of documentation that describes the design history of a finished medical device. Design history file dhf, device master record dmr, device history record dhr and technical file tf and design dossier john e. The article does not include a dhf template, but recommendations for format and content of a design history file are provided. Dmr is a set of documents containing procedures and specifications for a finished medical device. Upon completion of the design phase of a device, a formal document plan will be initiated and will be called the device master record. The importance of dhf, dmr, and dhr sanbor medical. Design history file dhf, device master record dmr, device history record dhr and technical file tf and design dossier. Device master record dmr another distinction of the technical file is the device master record dmr. Within the device master record dmr and design history file dhf for each product. Follow these best practices to implement an effective medical device design transfer process and avoid common mistakes. All cgmp manufacturers are required to keep separate master batch records mbrs and batch production records bprs in order to comply with fda regulations.
Device history record how is device history record abbreviated. Apr 01, 2019 the information on this page is current as of april 1 2019. White paper device master records and medical device files. There are three types of files specifically that cause a great deal of confusion. The total finished design output consists of the device, its packaging and labeling, and the device master record. The fda qsr and the medical device directive specify certain documents or records that should be included in your organizations quality. Whats the difference between a design history file dhf, device master.
Two key elements of the quality system regulation requirements for the fda cgmp are the device master record and the device history. Device master record index medical device engineering dmri. Device history records are authentic copies of a device master record that are use to document the specific information for an individual batch. Cogmedix stores dhrs in a safe and secure location with an electronic backup. Design history file dhf, device history record dhr. Medical device standard operating procedure template describes the organization, content, creation and use of the device master record employed in the production of all medical devices distributed by the company. The design history file dhf gives a history of device design. Content of dhf, dmr and dhr for medical device software part 3. The quality system at cogmedix ensures that dhrs are maintained in accordance with the device master record dmr. While these three acronyms can see confusing and easily interchangeable when you first hear them, if you look at the actual terms, they. Weve also combined all three posts into one easytoread pdf, plus. Dmrdevice master record vs dhfdesign history file vs dhrdevice. Best practices for maintaining device master records dmr.
Overview of medical device dhf, dhr and dmr oriel stat a matrix. Cogmedix maintains medical device history records dhr in accordance with the requirements of the 21 cfr 820. The fda qsr and the medical device directive specify certain documents or records that should be included in your organizations quality systems design history file dhf, the device master. Device master record example 2 from phar 6030 at university of georgia. The device master record dmr contains all the information necessary manufacture, install, service, and maintain the device. Understanding the differences and what documents to include read more the beginners guide to design verification and design validation for medical devices. Instantgmp generates device history records that keep track of. These records, while confusingly similar in name, are quite different in purpose and are cornerstones of the design control process. Each manufacturer shall maintain device master records dmrs. Feb 02, 2015 design history files dhf, device master records dmr, and device history records dhr are key building blocks used in the design, development, manufacturing, and cgmp compliance for the. Sep 11, 2015 the device history record is meant to be a collection of records containing all productionrelated documentation of a device that has been manufactured and released into inventory. Medical device master record, history record, dhr, dmr.
Each manufacturer shall ensure that each dmr is prepared and approved in. The device master record dmr is an allencompassing collection of documents and records including device specifications, process specifications, quality assurance procedures, and packaging and labeling specifications mandated by 21 cfr part 820. Dmr is a set of documents containing procedures and specifications for a. Dmrdevice master record vs dhfdesign history file vs dhr. Device master record example 1 device master record. The cgmps mandate design control and proof of compliance in the design history file dhf. Dhr for each batch or lot, to demonstrate it has been built in accordance with its device master record, and must include all dates, quantities. The manufacturer maintains a dhr device history record which has all the. Manual routing of paper ecos in colored folders is inefficient and prone to.
Maintaining the device master record arena solutions. The dmr for each device type shall include or refer to the. Design history file dhf, the device master record dmr. The dmr for each type of device shall include, or refer to the location of, the following information. Device master record dmr the dmr needs to be developed for each type of medical device and will include the following information as a minimum. Records are important device master record, device history record.
The design history file, or dhf, is part of regulation introduced in 1990 when the u. Each manufacturer shall establish and maintain procedures to ensure that dhrs. The device master record dmr can be thought of as the definitive. The goal is to be able to provide proof that the device in question was manufactured according to the requirements spelled out in the device master record dmr. There are key regulatory documents global medical device companies must meet for the u. The device master record procedure prescribes the responsibilities for preparing device master records dmr and to ensure the completeness of dmr indexes indices. The device master record contents template is a listing of items that may appear in a device master record. While these three acronyms can see confusing and easily interchangeable when you first hear them, if you look at the actual terms, theyre surprisingly descriptive. Each manufacturer shall maintain device history records dhrs. The device master record is often referred to as simply dmr. The requirements for medical device files in iso 485. Device history record how is device history record. The approved, released specifications for the finished device. A dmr device master record details the specific material.
The design history file dhf the device history record dhr the device master record dmr change controls impact of change controls on each. Oct 07, 2015 the device history record is meant to be a collection of records containing all productionrelated documentation of a device that has been manufactured and released into inventory. Creating design history files dhf, the device master. Device master record dmr compilation of records containing the. Device master record index how is device master record. Second, manufacturers engineer and design the products. In the world of medical device development and manufacturing, document control is critical. We ve also combined all three posts into one easytoread pdf, plus. These functions, including the units, device history file or specification, and device master record or master batch record, can be electronically tracked by a plm system. There are so many different technical terms, documents, and acronyms you need to know working in the medical device field.
Device master record dmr what needs to be recorded. The device history record is meant to be a collection of records containing all productionrelated documentation of a device that has been manufactured and released into inventory. Brief introduction to lean documents and lean configuration quality system regulation, 21 cfr part 820, and iso 485 as it applies to dhf, dmr, and dhr design history files dhf content, development, and management device master records dmr content, development, and management device history record dhr content, development, and management. Nov 19, 2018 device master record dmr the dhf shows how you developed your recipe, but the dmr is the recipe itself. Device history file dhf is the collection of lot of records that will define the frozen design that includes the design, risk assessment and a plan for making. The device master record should be accurate and complete because the essence of the qs regulation is a quality system based on designing a device to meet user needs, documenting the design and production procedures in the device master record and then producing a finished device that meets the device master record requirements. A device master record should be prepared and maintained for all devices products manufactured or under development. The quantities of raw materials and ingredients that went into a batch. How to prepare your design history file dhf for an fda. Dmr device master record vs dhfdesign history file vs dhr device history record. In other words, it contains all the information needed to produce the device. February 1, 2008 example 2 example 2 compliant company, inc. The device history record dhr is outlined in the us fda quality system requirements, part 820, section 184.
The term is used in quality management systems that cover product design and production. Items such as the product type, its time frame, quantity, and plant information all belong in an erp system. Cogmedix maintains medical device history records dhr in accordance with the requirements of the 21 cfr 820 the quality system at cogmedix ensures that dhrs are maintained in accordance with the device master record dmr cogmedix stores dhrs in a safe and secure location with an electronic backup dhrs are uploaded on ftp sites for easy retrieval for our customers. Congress passed the safe medical devices act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. Each manufacturer shall establish and maintain procedures to ensure that dhrs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the dmr and the requirements of this part. Sop 1602 device history record dhr by pj brackett on prezi. Package consists of the procedure and a device master record index log. A device master record is a compilation of all the instructions, drawings and other records, that must be used to produce a product. The device history record demonstrates that a particular unitbatchlot was made according to the recipe. Bill of materials pull sheet how do we know the dhr is complete. Fda requires the use of a device master record dmr for medical devices.
Vp and qaqc supervisor sign the dhr this indicates. Design history file dhf, device master record dmr, device. Dmrdevice master record vs dhfdesign history file vs dhrdevice history record. A couple of weeks ago i announced that i will be conducting a webinar today i. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Design history file dhf, the device master record dmr and. Device master records and medical device files how do they compare. Best practices for an effective medical device design transfer process. Manufacturers and suppliers of medical devices must manage. Dhr for each batch or lot, to demonstrate it has been built in accordance with its device master.
Each manufacturer shall establish and maintain a dhf for each type of device. This webinar is beneficial for any professional who is involved with a design effort from the time management releases funding to develop a new device design. Dhf template format and content of design history file. The device history record dhr has the objective evidence to support the device production. Best practices for an effective medical device design. The dhf shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design. This includes details of the all components, all software, any. Device master record index how is device master record index abbreviated. Overview of medical device dhf, dhr and dmr oriel stat a. Where the device master record device history record tie in. Device master record dmr what needs to be recorded into.
A device master record is a compilation of all the instructions, drawings and other records, that. Device master record example 1 from phar 6030 at university of georgia. Master batch records, also known as master manufacturing formulas, are. This includes details of the all components, all software, any applicable formulation and composition. Device master records and medical device files are fda requirements. Friday facts device history record biological indicators. Device master record example 2 uncontrolled copy valid. Each manufacturer shall ensure that each dmr is prepared and approved in accordance with 820.
This is basically the recipe for a device, including listing of components, pieces, materials, drawings, specifications, inspection procedures, manufacturing instructions and anything else that goes into its production. One of the design outputs is the device master record dmr. Initiate a postmarket surveillance pms plan for the new product or update an existing pms plan for a product family. The device history record dhr demonstrates that each batch, lot, or production. Design history files dhf, device master records dmr, and device history records dhr are key building blocks used in the design, development, manufacturing, and cgmp compliance for the. Developing dynamic device history records mddi online. Jul 25, 2016 the history and information on how you made the device in accordance with the dmr is stored in the dhr. Nov 16, 2017 there are so many different technical terms, documents, and acronyms you need to know working in the medical device field.