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First Audit Design Controls Checklist

Thirty questions across ISO 13485 clause 7.3, each with the evidence an auditor will ask to see. Score your design history file in under an hour and see which areas to fix first.

• Planning to changesCovers clause 7.3.2 through 7.3.10.
• Evidence for each itemShows the record an auditor will ask to see.
• Simple scoringRate each item as met, partly met or missing.