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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
Design history file - Wikipedia A design history file is a compilation of documentation that describes the design history of a finished medical device
What is DHF (Design History File)? What You Need To Know The design history file (DHF) is a formal, organized documentation of all the product design and development processes pertaining to a finished medical device The creation of a DHF is the last step in the design controls process mandated by the FDA in 21 CFR Part 820
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Design History File (DHF): Everything you need to know - Scilife A DHF is mandatory under FDA 21 CFR Part 820 and ISO 13485, proving your medical device was designed safely and compliantly A DHF documents every step of the design control process, from planning and inputs to validation, transfer, and changes
What Is A Design History File (DHF)? - Freyr Solutions The Design History File (DHF) was first mandated by the United States FDA in 1990 as part of the safe medical devices act; it contains all the product development documentation pertaining to a finished medical device
What is a DHF? - Medical Device Academy DHF is an acronym for design history file The US FDA is the only country that specifically includes this in medical device regulations (i e , 21 CFR 820 30j) Other countries simply require that you maintain records of design and development
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
Demystifying DHF for Medical Device Software - Sequenex As medical device manufacturers navigate the complex landscape of regulatory compliance, one crucial aspect often causes confusion: the Design History File (DHF) DHF serves as the roadmap of a product’s development journey, containing vital documentation and evidence of compliance
Design History Files: Everything You Should Know What is a Design History File (DHF)? A Design History File’s definition is a set of documents that serves as a comprehensive record of a medical device’s design and development planning A medical device manufacturer must have a DHF for each medical device type