Design History File (DHF): Definition and Requirements A Design History File (DHF) is a structured compilation of records documenting the design and development process of a medical device, ensuring adherence to design controls and regulatory requirements
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Design history file - Wikipedia A design history file is a compilation of documentation that describes the design history of a finished medical device
How to Create a Design History File (DHF) for Medical Devices The Design History File (DHF) is more than just a regulatory requirement; it’s a cornerstone of medical device design and development A well-maintained DHF ensures compliance, facilitates regulatory approvals, and provides a roadmap for future device iterations
Assembling a Design History File for your medical device The Design History File (DHF) and Device Master Record (DMR) are like a medical device recipe and contain all of the information that’s needed to actually make the device
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