As of today, the FDA has approved about 1,451 devices by March 2026, according to an external analysis of the FDA database AI/Ml devices. However, most SaMD sponsors have filed incorrect classifications, resulting in wasted time . FDA is requesting Predetermined Change Control Plans. EU is requiring compliance with the AI Act + MDR. ISO is requiring 42001. Your organization needs a unified story-line across all three.FDA GMLP, PCCP, ISO/IEC 42001, EU AI Act, and Good Machine Learning Practice — five overlapping frameworks, zero settled precedent. Get this wrong and your AI/ML submission becomes a science project.
Our solution
AI-specific regulatory strategy bridging FDA, EU MDR, EU AI Act, and ISO/IEC 42001 for AI/ML SaMD. We have authored PCCPs that cleared review. coordinate your development activities to be aligned with ISO/IEC 42001, and facilitate your compliance with the FDA's AI Action Plan and EU AI Act simultaneously. Development of regulatory strategy for Artificial Intelligence that spans FDA, EU MDR, EU AI Act, ISO/IEC 42001 and Good Machine Learning Practices.
Process
How we run this engagement.
Discovery
Free consult on AI/ML pathway and classification
Strategy
PCCP, GMLP, and Annex II AI-mapping, data governance
Authoring
SaMD submission with locked algorithm change protocol
Agency liaison
Pre-Sub and Q-Sub for AI-specific risks
Lifecycle
PCCP execution, Real World Performance/post market surveillance
FDA GMLP, PCCP, EU AI Act and ISO/IEC 42001 for AI/ML SaMD.
How we help
AI-specific regulatory strategy bridging FDA, EU MDR, EU AI Act, ISO/IEC 42001 and Good Machine Learning Practice.
