What is medical device computer system validation?

Medical Device Computer System Validation (CSV) is the process of ensuring that software and computer systems used in the manufacturing, testing, or management of medical devices meet regulatory requirements and function as intended. This involves documenting that all systems are installed correctly, operate reliably, and consistently produce accurate data. CSV is critical for patient safety, product quality, and regulatory compliance, particularly with standards like FDA 21 CFR Part 11 and ISO 13485. The validation process typically includes planning, risk assessment, testing, and ongoing monitoring throughout the system's lifecycle.