Design verification is performed to ensure that the design and development outputs have met the design and development input requirements. Design inputs include device functional, performance, usability and safety requirements according to the intended use, regulatory requirements and standards, information derived from previous similar designs, and risk management. When defining your design inputs, take into consideration how you will verify these inputs. To help ensure you have met all of the design necessities, create a table reflecting the design inputs your device requires as well as the method of verification for reference. There are medical device companies familiar with device design controls available to assist with verification of your device design.
Design validation demonstrates the device meets the user needs and intended uses. Design validation requires that you first define user requirements in the design input stage. The design validation must ensure that your device will conform to the defined user needs and intended uses and includes testing of production units under actual or simulated use conditions. Device validation also includes software validation and risk analysis.
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