Fda design history file medical device

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The DHF regulations allow medical device companies to present their DHF as a document that references the product development documentation for your medical device.

Greenlight's QMS acts as a secure reference library that holds all of your product development documentation where you can quickly and easily link to it from your DHF. Instead of assembling, photocopying, and perpetually updating a physical file folder with hundreds of pages, medical device companies can produce and update one document for their DHF that references the documents in the QMS.

Looking for a design control solution to help you bring safer medical devices to market faster with less risk? Read Blog Post. Sometimes, we find that companies have left out the creation of design controls and DHF.

See the Demo. You'll have to refer to subsection j for the specific text on DHF, but we managed to squeeze it in below: "j Design history file. If you make similar versions of the same device and the designs are the same, you can include all of the data in a single DHF. The DHF demonstrates that the device was developed in accordance with both the design plan and the requirements of this part. Your design plan must reflect compliance with the design controls process and should be included as part of the DHF.

Your completed DHF reflects compliance with the design controls mandate and your design plan. That discussion of the requirement indicated that the DHF is intended to be a repository of the records required to demonstrate compliance with your design plan and your design control procedures.

The discussion also indicates that the same DHF may be used for minor variations of a device such as size differences. Most manufacturers will organize the DHF in a binder and organize the binder chronologically to match a design project plan, however, most do not create a DHF template. Meeting minutes from each design meeting are typically included as an appendix to the DHF, while reviewed and approved documents such as the design plan, design inputs, design outputs and records of design reviews typically comprise the bulk of the DHF.

Manufacturers also typically will conduct an internal auditor of active DHF binders in order to ensure that design projects are following the approved design plans. The DHF is is intended to provide evidence of following an approved design plan, but the DHF consists of many records—not just one record.

A DHF template could be created to follow a standardized design control process, but most manufacturers write a generic design procedure that allows and encourages the design team to customize the design plan to match the needs of each development project. Therefore, design plans may have different numbers of design reviews and very different testing activities prior to the start of the design transfer process and during design verification and validation.