In today’s breakdown we’re going to focus on 21 CFR Part 820 – Subpart C Design Control – Section (E) Design Review
21 CFR Part 820 – Subpart C Design Control – Section (E) Design Review
“(e) Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).”
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