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A device history record (DHR) refers to a compilation of records containing the production history of a finished device and is defined under Subpart M 21 CFR Part 820 (Section 820.184). Section 820.184 states, “Each manufacturer shall maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture
(b) The quantity manufactured
(c) The quantity released for distribution
(d) The acceptance records, which demonstrate the device is manufactured in accordance with the DMR
(e) The primary identification label and labeling used for each production unit
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used
The DMR is a recipe that includes all of the components, specifications, and drawings needed to construct the medical device. The DHR comprises all data from manufacturing important to proving consistent quality features have been satisfied, as well as all information to offer evidence for satisfying the specification.
*Source: https://www.avanti-europe.ch
A design history file is a collection of documents that describe a medical device’s design and development activities. Its goal is to show that the device was developed in accordance with the approved design plan and requirements specifiec in FDA Title 21 CFR Part 820.
A device master record (DMR) provides all of the information and specifications required to manufacture a medical device from start to finish, including manufacturing process instructions, drawings, documented specifications and labeling, and packaging requirements.
See how Arena’s product-centric quality management systems (QMS) helps medical device companies manage the device master record and ensure compliance.
