The following are some of the key requirements of the DHF that medical device organizations should take into account. Subsequently, you can export and share your DHF with relevant external agencies. You can also easily make “snapshots” of your DHF and save all records at a given point in time to a Document Collection.

Non-conformance report in case of non-conformances or any abnormalities identified during the production processīy using the QMS software solution you can maintain the Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) structure and have the same record reside in multiple structures (DHF, DMR, DHR) at the same time.

Production records, including manufacturing date.

The DHR should be maintained for every lot or batch of a given medical device.Įxamples of documents and records that could be included in a Device History Record (DHR) are: DHR is generally record-keeping and serves to track the production process.

Process and instrumentation (P&I) diagramĭevice History Record (DHR) represents the production process of medical devices and must demonstrate the fulfillment of the Device Master Record (DMR).It also includes the equipment detail and the acceptance criteria, for example: It consists of design requirements and the production process. It could contain:ĭevice Master Record (DMR) includes all the information necessary for manufacturing the designed product. In reality, these terms are not similar and represent different product life cycle stages.ĭesign History File (DHF) represents all the steps and processes carried out during the design phase and acts as a basic guideline for developing a product. How Does Design History File (DHF) Differs From Device Master Record (DMR), and Device History Record (DHR)?ĭHF, DMR, and DHR are three major terms associated with medical devices and are sometimes confused with each other. Additionally, DHF is part of Premarket Notification – US FDA 510(k) by the manufacturers, requiring the manufacturers to notify FDA about their product at least 90 days in advance.Ĭonsider using QMS software to maintain traceability of your Design History File (DHF) and manage your 510K submissions with ease. A DHF is a regulatory requirement and must consist of user-focused attributes and requirements to fulfill user needs and expectations.Ī well-organized Design History File (DHF) is mandatory for medical device manufacturers for designing a product that best fits the end user’s requirement.

It includes all the stages and processes through which a medical device’s design phase evolves and finalizes. Additionally, the design phase is as per the approved design plan. It is used to provide evidence that all the design control procedures were appropriately applied and documented. Software to Manage Your Medical Device DHFĪ Design History File (DHF) shows the design history of a medical device.What Must the Design History File (DHF) Include?.How Does Design History File (DHF) Differs From Device Master Record (DMR), and Device History Record (DHR)?.The primary function of the DHF is to provide documented evidence that the device’s design phase is following the approved design plan and the component serves the user needs for which it is developed.

The Design History File (DHF) is a collection of documents that outlines the design history of a medical device.Ī DHF is one of the first documents that a regulatory body such as the FDA inspects for accrediting purposes.

Design dossier definition