GG VS Q2 2026 - AI, PCCP, and the upcoming FDA requirements that will catch SaMD teams off guard

The regulatory environment for AI/ML-enabled software as a medical device is evolving faster than most teams realize. The predetermined change control plan (PCCP) final guidance, updated FDA transparency expectations, and emerging international requirements are creating obligations many teams haven't incorporated into their quality systems. This session makes these concrete and actionable. It covers what PCCP requires, who needs one, and why it matters even for teams that aren't shipping AI features today. It also addresses where the real submission risk sits right now: the gap between what FDA has finalized and what teams have actually implemented. For teams with AI on their roadmap rather than in production, this session provides the regulatory context to prepare before requirements land on your submission timeline.