Bio-AI Regulatory Compliance and Validation

We engineer the complete technical file, including Algorithm Change Protocol (ACP), SaMD risk management, and validation reports, for FDA 510(k), De Novo, or PMA pathways. This ensures your AI/ML model is submission-ready, avoiding costly regulatory delays.

We build the comprehensive documentation required under EU MDR/IVDR, including clinical evaluation reports for AI-based diagnostics and performance evaluation plans. Our work ensures conformity with Annexes II and III, facilitating CE marking for the European market.

We implement fully traceable, audit-ready MLOps pipelines that enforce GxP principles for data integrity (ALCOA+) across the entire model lifecycle—from development and training to deployment and monitoring. This is critical for AI used in clinical decision support or manufacturing.

We design and execute statistically rigorous validation studies to demonstrate clinical safety and effectiveness. This includes protocol development, multi-site coordination, and analysis to generate the high-quality evidence required for regulatory approval and payer reimbursement.

We deploy immutable logging and version control for all model artifacts, training data, and hyperparameters. This automated system provides a complete lineage for regulatory audits and internal quality checks, turning compliance from a manual burden into an automated advantage.

We build continuous monitoring systems that track real-world model performance, detect data drift, and trigger required updates per your approved Algorithm Change Protocol. This proactive PMS reduces regulatory risk and maintains model efficacy after launch.