• Understanding Dual Compliance: Applying MDCG 2025-6 guidance to understand the interplay between the MDR/IVDR and the EU AI Act for high- risk systems
• Embracing the Total Product Lifecycle (TPLC): Moving beyond static “snapshots”; approvals by using the FDA’s finalized Predetermined Change Control Plans (PCCPs) to manage adaptive algorithms.
• Helping De-risk Innovation through Sandboxes: Applying lessons from the UK MHRA AI Airlock and EU regulatory sandboxes to validate synthetic data, large language models (LLMs), and real-time monitoring
• Standardizing AI Governance: Leveraging ISO 42001 and IMDRF Good Machine Learning Practice (GMLP N88) to meet applicable AIA Article 10 requirements for data quality, bias mitigation, and performance drift.
• Navigating Surgical Autonomy: Managing "human-in-the-loop" oversight and closing the liability/responsibility gap as robotic platforms advance through higher levels of autonomy (Levels 0–5)
• Validating Cybersecurity: Aligning secure-by-design; principles with new AI system vulnerabilities, adversarial threats, and post-market vigilance requirements