Design Verification & Validation

Design-Validation-300x190Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.

Libra Medical’s staff members are experts in designing Validation and Verification plans, including Software Validations.

Design Verification: Did I make the product correctly?

Design Validation: Did I make the correct product?

Design Verification:

  • Each manufacturer shall establish and maintain procedures for verifying the device design.
  • Design verification shall confirm that the design output meets the design input requirements.
  • The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the Design History File.

The basis of verification is a three-pronged approach involving tests, inspections, and analyses. Any approach which establishes conformance with a design input requirement is an acceptable means of verifying the design with respect to that requirement. In many cases, a variety of approaches are possible.

Design Validation:

  • Each manufacturer shall establish and maintain procedures for validation 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 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.