The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices …

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Feb 3, 2025 · 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 …

Jun 4, 2018 · 「DHF指的是設計開發管制流程 (Design Control)下所產出的相關文件．簡單來說就是 “如何將無形的客戶/臨床需求轉變成有形的產品規格”以及“如何建立可穩定生產的產品規格” …

Combat modern-day slavery & human trafficking to stop exploitation, loss of freedom, and identity, and educate about the causes, stakes and consequences of slavery. The mission of DHF …

Feb 13, 2025 · Design History File (DHF) is a compilation of organized records that describes the design history of a finished medical device according to FDA 21 CFR 820.30. The DHF is …

Jun 26, 2022 · Heart failure is a condition where your heart is unable to pump enough blood to meet all your body's needs. When heart failure becomes severe enough to cause symptoms …

Jun 9, 2017 · When you see the acronym “DHF” this is talking about the design history file, which is simply the collection of documents from the design and development process. Here’s how …

May 29, 2024 · The design history file (DHF) is focused on capturing the history of the design and ensuring that it was done according to FDA regulation. The device master record (DMR) is …

A technical file in a lot of ways is a DHF but emphasizes your device's safety, performance, and adherence to regulatory requirements for the European Union. These three files serve distinct …