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Design Dossier/DHF Updates - What to Keep

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ElizSurg

#1
Hello, I would really appreciate if someone could help me with the following query
My company is currently in the process of putting together procedures for Tech Files and Design History File. When a product is released, which should you keep as your live file (updating risk document, Essential Requirements, etc.) Can it be either one once you define where the updates are being made?
I would appreciate your guidance as I am new to this. The amount of documents that need to be created is comprehensive. I want to try and make the process as stream lined as possible for updating once a product is released.
Thanks for taking the time to read my post ...much appreciated :D
 

John Broomfield

Staff member
Super Moderator
#2
Hello, I would really appreciate if someone could help me with the following query
My company is currently in the process of putting together procedures for Tech Files and Design History File. When a product is released, which should you keep as your live file (updating risk document, Essential Requirements, etc.) Can it be either one once you define where the updates are being made?
I would appreciate your guidance as I am new to this. The amount of documents that need to be created is comprehensive. I want to try and make the process as stream lined as possible for updating once a product is released.
Thanks for taking the time to read my post ...much appreciated :D
ElizSurg,

The records generated by the design process and related processes:
  1. The product design plans (as kept up to date throughout the design)
  2. Design authorities and responsibilities
  3. Evidence of competence to fulfill authorities and responsibilities
  4. Design inputs (particularly the performance spec for the product under design)
  5. Design reviews (particularly issues and their resolution)
  6. FMEAs and other risk assessments
  7. Design validation plan and any changes
  8. Copies of verified design outputs
  9. Validation and revalidation results
  10. Copies of specs and drawings issued for purchasing and manufacturing
  11. Design changes including any repair or use as is disposition of NC product
  12. Copy of the user manual and any training manuals
That's about it!

John
 
Last edited:
#3
The Technical file for CE marking is a mix of the Design History File and Device Master Record from the FDA. The technical file is also a summary of the device design documents, not all the documents themselves. Even the DHS can be thought as a list of separate documents (which is better to updating)

I now it?s not a very good answer, but in practice, you should update what needs updated. For example, if you update your risk assessment but the result is not a change to the way the device is manufactured (the DMR), you only need to update your risk assessment (and if you use the technical file and DHS as index, you do not need to update them in principle unless you control them by numbers and the numbers change).
 
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