Validation is the process of demonstrating that a medical device or system meets all the requirements specified in the applicable regulations, standards, and specifications.
Achieving validation requires a comprehensive approach that incorporates design controls, risk management, manufacturing controls, and testing and the objective of validation is to ensure that devices are safe and effective when used as intended so Validation is an important step in bringing a medical device to market. It helps to ensure patient safety and provides assurance that the device will perform as intended under real-world conditions.
