Failure to establish and maintain procedures for validating the device design to include validation and to perform design validation under defined operating conditions on initial production units, lots, or batches, or their equivalents; and failure to ensure that devices conform to defined user needs and intended uses and to include testing of production units under actual or simulated use conditions including software validation and risk analysis where appropriate, as required by 21 CFR 820.30(g). For example, there are no established and maintained written procedures for validating the device design to ensure the devices conform to defined user needs and intended uses and to include testing of production units under actual or simulated use conditions.