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Device History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
A design history file is a compilation of documentation that describes the design history of a finished medical device.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.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file (medical device file, device master record, design dossier, or device master file). Annex II and III of the EU medical device regulation (MDR) and of the In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and ...
Upload file; Search. Search. Appearance. ... Medical Devices regulations cover all the topics related to the laws, ... Design history file; Device Master Record; F.
A file containing your data will then start to download to your computer or device. Cancel your download request: 1. Go down to "Download Request In Progress." 2. Click Cancel the download request. 3. Beside the current download request, click Cancel request.
Device Master Record, a compilation of all the instructions, drawings and other records that must be used to produce a product; Differential Microwave Radiometer, an instrument on the Cosmic Background Explorer satellite; Digital Media Renderer, a DLNA-compliant device used to stream and play content
Malware refers to several different types of malicious software created by cybercriminals to gain access to your devices and steal personal information or cause damage. Check out the infographic ...
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