Medical device design history file

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. Learning Center. GxP-Lifeline Blog Read our newest articles from our industry experts.

Resource Center Search our collection of authoritative publications. Customer Stories Watch our customers share their successes. About Us. Careers We are growing fast and look for people to join the team. Become A Partner Learn about the variety of partnerships available in our network. Events Explore the upcoming events. Masters Summit Learn about the upcoming industry event. GxP Lifeline. Design input. Design output. Design review. This means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials.

Design and development planning - include your design plan document, developed according to this part. Design input - include procedures for establishing design input that addresses the intended use and user needs learn about establishing user needs here , and the approved design input documentation itself. Design output - include your procedure for defining and documenting design output in compliance with this part, and the approved design output documentation itself learn more about design inputs and outputs here.

Design review - include your procedure for conducting reviews of your design process and any documentation related to the reviews that were conducted. Design verification - include a document describing your design validation process and the approved results of the design validation Design validation - include the specific procedure and testing conditions used for design validation, as well as the approved results of the design validation process read more about design verification and validation here.

Design transfer - include the documented product specifications that are developed in compliance with this part and a description of the process used also check out our guide to design transfer best practices. Design changes - include the documented design change process and documentation pertaining to any design changes that have taken place.

Are you interested in learning more about our Quality Management Software? About Us. Careers We are growing fast and look for people to join the team. Become A Partner Learn about the variety of partnerships available in our network. Events Explore the upcoming events. Masters Summit Learn about the upcoming industry event.

GxP Lifeline. The best way to get through an FDA inspection is to always be prepared for one. Inspection Guidance in the QSIT Manual Preparation includes the person responsible for the design control process understanding what to expect.

The manual identifies four major subsystems: Management controls. Design controls. Corrective and preventive actions. Production and process controls.