As mentioned in other discussions, ensuring an adequate design control would lower the risk of a product failure at any point.
Design Controls, in general, were explained a lot in this discussion, thus I wanted to discuss in particular the Design validation section.
Each medical device would go through a validation process (examination tests) to ensure the design output, results, efficiency, accuracy, etc. This would also check whether the device specifications does meet the intended use needs. FDA has its requirement in the design validation (820.30 (g)).
The main requirements include the following:
“-Each manufacturer shall establish and maintain procedures for validating the device design.
– Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.
– Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.
– Design validation shall include software validation and risk analysis, where appropriate.
– The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the Design History File”

Ref. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf