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.

Develop and validate AI models that simulate patient cohorts and predict drug efficacy/toxicity to support regulatory filings under FDA's Digital Health Software Precertification Program. We ensure model transparency and rigorous statistical validation.

Achieve FDA 510(k) or De Novo clearance for AI/ML-based SaMD (Software as a Medical Device). Our process covers the entire lifecycle from design controls and algorithm change protocols to clinical validation per IMDRF guidelines.

Implement GxP-compliant MLOps pipelines for generative models creating novel therapeutic candidates. We establish audit trails, data integrity controls (ALCOA+), and validation documentation required for IND/CTA submissions.

Build ISO 13485-certified development processes for AI models identifying predictive biomarkers from multi-omic data. Our validation ensures analytical and clinical validity for CDx co-development with therapeutics.

Deploy validated NLP systems for automated adverse event signal detection from EHRs and scientific literature. We ensure compliance with 21 CFR Part 11 and EU MDR requirements for post-market surveillance.

Architect and validate secure, locked/frozen, or continuously learning AI models under the FDA's predetermined change control plans. We implement rigorous monitoring, bias detection, and re-validation protocols.