Ensuring a medical device meets defined user needs and intended use is accomplished through which type of validation?

The correct choice relates specifically to "Design Validation." This type of validation is critical in the medical device development process as it ensures that the device aligns with user needs and intended use. Design validation is typically conducted through a combination of methods, including usability testing, clinical evaluations, and simulated environments to confirm that the product functions correctly and meets the defined requirements.

Design validation is distinct from other types of validations because it specifically focuses on assessing whether the final product design fulfills its intended use and satisfies user needs. It verifies that the design outputs meet the design inputs, which include regulatory requirements, safety, and effectiveness criteria. This is crucial in demonstrating that the medical device can safely and effectively perform its intended tasks in real-world scenarios.

Other options may represent different aspects of product development but do not specifically address the validation of user needs and intended use in the same structured manner. Design validation plays a vital role in ensuring that manufacturers can confidently release a device that meets both regulatory and customer expectations.