SaMD Clinical Validation
AstraOne runs the prospective clinical studies that bring Software as a Medical Device — including AI/ML-enabled algorithms — through FDA clearance and post-market evidence.
What we deliver
SaMD clinical trials
Pivotal and confirmatory studies for diagnostic, prognostic, and therapeutic SaMD.
Algorithm validation
Locked-model validation with pre-specified sensitivity, specificity, and generalizability criteria.
AI/ML medical device validation
Prospective clinical validation for AI/ML SaMD, including subgroup and bias analyses.
Reference standard adjudication
Blinded expert adjudication panels with pre-specified rules and inter-rater analysis.
Real-world performance studies
Post-market performance monitoring aligned with FDA PCCP frameworks.
Clinical evaluation for SaMD
Clinical evaluation reports supporting FDA, MDR, and international submissions.
Built for regulatory-grade evidence
- Aligned with FDA SaMD, GMLP, and PCCP guidance
- Locked-model and adaptive-model study designs
- Bias, fairness, and subgroup analysis expertise
- Integrated clinical, statistical, and regulatory strategy
Frequently asked questions
What is SaMD clinical validation?
SaMD clinical validation is the prospective clinical study process that demonstrates a Software as a Medical Device performs safely and effectively in its intended population and use environment — required by FDA and international regulators before clearance.
Ready to scope your study?
Talk to our clinical operations team about protocol design, recruitment, and execution.