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DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact
Global Medical Device Podcast powered by Greenlight Guru
How to Build a Device History Record
Device history record (DHR) is created after going through design, development, and regulatory paperwork/nDHR is specific to each production batch or lot/nDHR records all information related to manufacturing, including material lots, production records, dates, labeling, and unique identifiers/nDHR provides traceability from raw material to finished goods/nDHR is a valuable source of information in case of failures or non-performance issues/nDHR helps in identifying manufacturing issues and building evidence against them/nDHR requirements are specified by the FDA
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