Drawings (tooling, fixtures, product, etc.).These specifications are typically composed of written documents, including: Now it’s time to make sure those design outputs are correctly translated into written production specifications. Your design is complete and you are ready for production. You’ve created all of your design inputs, defined the outputs, and conducted design verification. We’ve also combined all three posts into one easy-to-read PDF, plus added some extras. In the first post we talked about the basics followed by design inputs and outputs. To view more observations pertaining to DHR, refer to the following GMP Trends® Issues: 1083, 1077, 1072, and 1071.This is the last in a 3-part blog series on medical device design control. All DHRs were reviewed and approved.įor more information on device history records and the differences between DHF (design history file), DMR (device master records) and DHR (device history record) see FDA presentation, Documents, Change Control and Records and the transcripts to the presentation. These deficiencies were not identified as nonconformances. DHR for … lot … did not include data summarizing QA test results for product QA release. DHR for… lot … did not include data for all QA tests performed during the product QA release process.ĭ. DHR for … lot … did not include a … QA Solution Preparation form.Ĭ. DHR for … lot … noted the amount of … added to the … solution as … however, this amount does not match the amount of … specified in the product’s formulation.ī. A device history record has not been adequately maintained.Ī. Any unique device identifier (UDI) or universal product code (UPC), and any other device identifications(s) and control numbers(s) used.The primary identification label and labeling used for each production unit.The acceptance records with demonstrate the device is manufactured in accordance with the DMR.
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