Design 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?