PCCP 101
This white paper provides a comprehensive guide to Predetermined Change Control Plans (PCCPs) for AI/ML-based medical devices. It covers essential aspects such as regulatory frameworks, risk management, validation procedures, and the utilization of real-world evidence to ensure compliance and safety. Designed for medical device quality and regulatory professionals, it offers practical insights and examples to navigate the complexities of managing device modifications.
This white paper provides a comprehensive guide to Predetermined Change Control Plans (PCCPs) for AI/ML-based medical devices. It covers essential aspects such as regulatory frameworks, risk management, validation procedures, and the utilization of real-world evidence to ensure compliance and safety. Designed for medical device quality and regulatory professionals, it offers practical insights and examples to navigate the complexities of managing device modifications.
This white paper provides a comprehensive guide to Predetermined Change Control Plans (PCCPs) for AI/ML-based medical devices. It covers essential aspects such as regulatory frameworks, risk management, validation procedures, and the utilization of real-world evidence to ensure compliance and safety. Designed for medical device quality and regulatory professionals, it offers practical insights and examples to navigate the complexities of managing device modifications.