AI, PCCP, and the upcoming FDA requirements that will catch SaMD teams off guard

Most SaMD teams know FDA requirements for AI/ML are coming. Fewer have read the actual guidance. Even fewer have mapped it to their quality system.

In this session from the Greenlight Guru Software Enabled Devices Virtual Summit, we break down what FDA's predetermined change control plan (PCCP) requirements actually mean for SaMD teams building AI-enabled devices, and what you need to have in place before these requirements start catching companies off guard.

Watch now!