How familiar are you with the requirements for Predetermined Change Control Plans (PCCPs)?
The PCCP is a structured, pre-approved plan for managing software updates in AI-enabled medical devices without requiring additional regulatory approvals for each modification. A compliant PPCP plan eliminates the need for multiple submissions and therefore reduces regulatory delays while maintaining compliance.
As such, the PCCP is an important strategic tool for medical device manufacturers and software developers that supports and streamlines the use of predetermined change control plans in submissions for medical devices with artificial intelligence (AI) features.
If you’re seeking guidance on building a PCCP or understanding how the FDA’s evolving cybersecurity requirements affect your devices, Evnia’s team of experts is here to help. Contact us to learn more.
Download your copy here: Evnia White Paper on Predetermined Change Control Plans
or read it online here.
