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 that can cause or contribute to the death, serious illness, or injury of a patient.

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2025年2月3日 · 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.

2018年6月4日 · 「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”這兩個過程之文件化，其中後者就是指DMR，所以完成了DHF也會產出DMR．」 美國FDA頒布了 21 CFR Part 820.30 - Design controls. 來說明該如何執行Design Control，而在最後一項 (j)即是解釋何為DHF，FDA的定義為 " Design history file. Each manufacturer shall establish and …

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2025年2月13日 · 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 essential to prove that the medical device has been created and produced in compliance with customer and regulatory requirements.

2022年6月26日 · 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 requiring immediate medical treatment, it is called decompensated heart failure (DHF).

2017年6月9日 · 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 the FDA describe it in 21 CFR Part 820.30 (j): “Each manufacturer shall establish and maintain a DHF for each type of device.

2024年5月29日 · 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 focused on building the device and ensuring that all necessary items are included to build, test, package, and service it.

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 purposes in the realm of medical device development and regulation.