Design history files compile requirements, specifications, design reviews, verification and validation testing, and change records. Medical device regulations mandate them, and other industries maintain equivalents.
They establish what the manufacturer considered during development.
Alternative Names:
DHF, Design Records
Why it Matters?
These files contain the material that determines design defect cases, including alternatives evaluated and rejected, hazard analyses identifying the risk at issue, and design review minutes recording internal disagreement. A file documenting thorough hazard analysis and reasoned rejection of alternatives defends the design, while one showing a known hazard dismissed for cost reasons does the opposite. The file is created long before litigation and cannot be improved afterward.
Frequently Confused with
Related terms
Frequently asked questions
What makes design history files decisive?
Can the file be improved after a claim?
