The Three Ds of the Product Development Lifecycle: DHF, DMR, and DHR
Table of Contents
The FDA requires manufacturers to adhere to regulations throughout the entire lifecycle of medical devices to enhance their quality and safety. These regulations start at the design stage and encompass aspects such as packaging, labelling, and post-market surveillance.
Throughout this process, manufacturers are faced with various codes and abbreviations, including section numbers, subparts, and abbreviations like DHF, DMR, and DHR. It can be confusing because these abbreviations look similar and are closely related.
However, understanding the requirements and how to comply with them is crucial. It not only helps manufacturers stay in compliance with the FDA but also enables them to streamline their processes, reduce costs and non-conformance, and enhance customer
Explain DHF, DMR, and DHR
To begin with, let’s elaborate on the meanings of the three acronyms
DHF – The Design History File (DHF) is a collection of documents, records, and procedures that provide a comprehensive history of a medical device’s design and development process. It details all the design and development activities, including design inputs, outputs, verification, and validation.
DMR – The Device Master Record (DMR) contains all the specifications and detailed instructions necessary to produce a medical device. It includes information on materials, components, assembly procedures, labelling, and packaging. The DMR serves as a reference for manufacturing, ensuring consistency and compliance with design requirements.
DHR – The Device History Record (DHR) is a compilation of records that tracks the production and quality history of each medical device. It includes information on the device’s manufacturing processes, inspection and testing results, and any deviations or non-conformities encountered during production. The DHR provides a documented history of each device, ensuring traceability and accountability.
DHF (Design History File)
Part C of 21 CFR Part 820 sets forth guidelines for ensuring that devices are designed to meet objectives and fulfil requirements. These guidelines, known as design controls, encompass the entire product design process, starting from planning and extending to the validation of design and finalization of specifications. Throughout the design process, there will be multiple iterations and modifications, necessitating repeated reviews, verification, and validation.
Complying with regulations requires capturing the entire design and development process in a document called the design history file (DHF). This file serves as evidence that the process aligns with the approved design plan and relevant regulations. In cases where a DHF is not available, the manufacturer must provide references to all relevant records for device specifications, product process specifications, and quality assurance specifications.
This can entail a wide range of documents, such as drawings, formulations, composition details, equipment specifications, and production procedures, all of which are utilized throughout the design process, including when transferring the design to the manufacturing team.
Having a DHF is crucial for efficiency and is particularly important during the later stages of the process.
DMR (Device Master Record)
As mentioned earlier, the Design History File (DHF) is responsible for capturing device specifications, packaging and labelling specifications, production process specifications, as well as quality assurance requirements and specifications. On the other hand, the Device Master Record (DMR) is a living document that contains the current list of specifications and testing requirements, as required by 21 CFR Part 820.40. It includes specifications for packaging and labelling methods and processes and also outlines procedures and methods for product installation, maintenance, and servicing, which should be easily accessible.
It is important to create the DHF diligently, as the DMR can reference its location.
While the DHF focuses on tracking the design history and its compliance with FDA regulations, the DMR ensures that all the necessary components for building, testing, packaging, and servicing the device are readily available.
DHR (Device History Record)
Once the design and components have been finalized, the next step involves the actual manufacturing process. The FDA requires manufacturers to establish and maintain procedures that are documented in the Device History Record (DHR) for each batch. This is necessary to demonstrate compliance with regulations and confirm that the device meets the required standards.
The DHR is a compilation of information from the Device Master Record (DMR) and the Design History File (DHF). It serves as a comprehensive record of the device’s journey and includes important details such as the manufacturing date, quantity produced, distribution information, records confirming the device’s conformity to the DMR, primary identification label, and associated labelling for each unit, as well as unique device identifiers and control
Automate all Three Documents to Ensure Efficiency and Correctness
The first and most intricate document requirement is the design history file (DHF). This comprehensive document meticulously covers all aspects of the product manufacturing process, from initial design to final distribution. It includes the product design, the specific components, and subassemblies to be utilized, the necessary testing criteria, and packaging and labeling guidelines.
Although it may appear straightforward, a significant portion of the design alterations that influence specifications also occur during this stage. Consequently, each modification must be carefully evaluated and approved before proceeding to the manufacturing phase. Detecting and addressing mistakes at this stage is far more advantageous for the product than discovering them later on during manufacturing or distribution processes.
Implementing a centralized, automated design process offers numerous benefits. It enhances efficiency, promotes team collaboration, enables early risk identification, and establishes control measures to address them. Furthermore, it aids in version control, ensuring the document remains up-to-date and minimizing the risk of errors arising from multiple versions.
Moreover, this streamlined approach provides systematic visibility to the Design History File (DHF) for Device Master Records (DMR) and Device History Records (DHR). This increased visibility improves compliance and conformity. Furthermore, it generates an audit trail that enhances traceability and accuracy.
Product Life Cycle Management (PLM), a robust system built on the trusted Salesforce platform, offers a seamless and cloud-based solution. Its exceptional integration capabilities with other critical enterprise systems like Supply Chain Management (SCM) and Enterprise Resource Planning (ERP) foster enhanced collaboration across all departments.
By ensuring universal access to the most up-to-date and pertinent documentation, PLM removes barriers to innovation, facilitating a dynamic and efficient work environment. This synergy of advanced technology and streamlined processes empowers organizations to adapt swiftly to market demands, optimize productivity, and drive continual innovation and growth.
~*~
- The Three Ds of the Product Development Lifecycle: DHF, DMR, and DHR - October 12, 2023