Design reviews are defined checkpoints throughout the medical device development process with an aim to ensure safety and effectiveness of the device. It also makes sure that each step of design controls is captured and documented during the product design phase. FDA asks manufacturers to establish and maintain procedures that ensure design review documentation. To facilitate the procedures, they should pre-define appropriate stages in the medical product development process for the design review.
The procedure requires to have three types of individual(s) during each design review stage:
- Individuals or representatives of all functions concerned with the particular design stage being reviewed An individual(s) who does not have direct responsibility for the design stage being reviewed Any relevant specialists for the concerned stage, if needed.
- The results of the design review should be documented in the design history file, which includes details such as identification of the design, the date, and the individual(s) performing the review.
