Automated validation and documentation for AI medical devices. Pre-validate your submission before the FDA does.
Average lost opportunity cost per delayed FDA clearance
Additional timeline when submissions fail validation
Average cost to bring a medium-complex AI device to market
The FDA is tightening requirements for AI/ML-enabled medical devices. Predetermined Change Control Plans. Data lineage documentation. Validation of training data quality. Bias detection. Every rejection forces resubmission, adding 6-12 months to your timeline.
At a $6.7M cost per delay, the traditional approach—scrambling to document after development—is a strategic failure. Regulatory consultants are expensive and slow. Your competitors are shipping while you're stuck in review.
Lucid's Clinical Validation Auditor embeds FDA-compliant documentation into your development workflow. Instead of retroactive scrambling, you generate the validation evidence the FDA needs as you build—reducing submission risk and accelerating clearance.
Automated creation of Predetermined Change Control Plan documentation showing how your model will be updated post-market.
Complete audit trail of training data sources, preprocessing steps, and validation datasets—with HIPAA-compliant handling.
Verification against FDA's Good Machine Learning Practice principles for medical AI development.
reduction in 510(k) documentation preparation
Pre-validation catches issues before FDA review
Data lineage tracking without exposing patient PII
Stop burning cash on delays. Start shipping with confidence.