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2. Device Master Record - Wikipedia

   en.wikipedia.org/wiki/Device_Master_Record

   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.

3. Design history file - Wikipedia

   en.wikipedia.org/wiki/Design_history_file

   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.

4. Technical file - Wikipedia

   en.wikipedia.org/wiki/Technical_file

   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 ...

5. DMR - Wikipedia

   en.wikipedia.org/wiki/DMR

   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

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8. Configuration item - Wikipedia

   en.wikipedia.org/wiki/Configuration_item

   Configuration items are represented by their properties. These properties can be common to all the configuration items (e.g. unique item code that we will generate, description of function, end of the lifecycle or business owner that is approving configuration item changes and technical owner, i.e. administrator, that is supporting it and implementing the changes).

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