Design Validation

The design control regulation requires that "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 DHF."

Design validation in fundamentally different from design verification. Whereas design verification seeks to establish that a product performs as intended, design validation seeks to determine whether that properly performing product is what the customer actually needs and whether it will perform in the user's real world environment.

Design validation activities broadly fall into two categories:

1. Quantification of the product's suitability, such as by customer evaluations or clinical trials

2. Various forms of stress testing that establish the robustness of the design

AlvaMed can help you structure a suitable design validation program that will not only meet your compliance requirements, but also assure you that you are releasing the right product to the market.

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