Risk Management

Ask the safety/device vigilance and PV CSV leads to: (1) confirm whether any marketed/fielded SaMD/AIaMD uses adaptive ML or planned updates that would fit a PCCP-like approach; (2) review current change-control SOPs and technical documentation to ensure change governance and transparency artifacts are captured and retrievable; (3) verify post-market/vigilance processes explicitly account for algorithm updates (e.g., monitoring after updates, escalation criteria).

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.