Documentation of Design changes

Mkm1989

Registered
What are some common practices in documenting design changes of class III products (assuming these are design changes: change of primary sterile packaging material or design, new size or shape of an existing device with same intended use, extending the indications for use based on new data etc)?
Which documents need revision for such changes?
Are design reviews mandatory for changes?
When should one create new DHF?
 

yodon

Leader
Super Moderator
13485 lays out the requirements for managing & documenting design changes. The documents to be revised will be based entirely on the change.

A review of the change is indicated by 13485 but unless you're doing some major design update, probably "design review" (per the standard) would not be indicated.

A DHF is a living thing, a compilation of all the design artifacts so it's updated with the change record and any other changed artifacts. Do note that the term "DHF" is going away with FDA's adoption of 13485 (effectively what 13485 calls "Design and Development Files").
 
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