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.
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