FDA (Food and Drug Administration) Guidelines for Software Validation

FDA guidelines for software validation ensure that medical software is reliable, safe, and effective. Validation involves systematically checking that the software performs its intended functions correctly through testing, documentation, and risk management. It includes planning, design, testing, and ongoing review to confirm the software meets regulatory standards and user needs. The goal is to prevent errors that could harm patients or compromise medical decisions. Overall, these guidelines promote thorough, documented processes to ensure medical software is trustworthy and safe for clinical use.