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This thread is carried over and continued in the Current Elsmar Cove Forums |
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This thread is carried over and continued in the Current Elsmar Cove Forums |
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 The Old Elsmar Cove Forums
 FDA and Medical Devices
 Design History File
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Mark Smith Forum Contributor Posts: 32 |
posted 25 May 1999 04:48 PM
  
Any ideas on the format I should use when my device is designed to be used WITH a drug? I am leaning towards a separate DHF for the device(s) and whatever the equivalent to a DHF is for the Drug. Suggestions? By the way I'm new to the site and not the same Mark as the site Administrator. IP: Logged |
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Don Winton Forum Contributor Posts: 498 |
posted 26 May 1999 11:32 AM
quote: That would be my suggestion. From the Medical Device Quality Systems Manual, Section 3, Design Controls: "Typical documents that may be in, or referenced·" Key word is referenced. Make a reference to the equivalent of a DHF for drugs in the device DHF. Another reason to maintain two DHF's is simplicity. Make the documents as simple to audit as possible and then the probability of an error of exclusion is less. Regards, ------------------ Check Out dWizard's Lair: IP: Logged |
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