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Tag: design history record

Home design history record

Managing DHF – Design History File Control for Medical Devices

By Waqas Imam0 CommentsGeneral
The United States Code of Federal Regulations Title 21 defines the DHF and its purpose for medical device manufacturers. According to Section 820.3(e) of the Federal Regulations: “Design History File (DHF) means a compilation of records which describes the design history of a finished device.” Similarly, Section 820.30(j) of the…
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  • Home
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