SaMD Classification & Risk Framework
Determine SaMD classification levels using IMDRF frameworks, FDA guidance, and international standards to align your product risk profile with the appropriate regulatory pathway.
Software as a Medical Device Intelligence
Navigate SaMD-specific regulatory complexity with AI-powered classification, lifecycle compliance, cybersecurity strategy, and predetermined change control planning.
Capabilities
SaMD Lifecycle Capabilities
Specialized intelligence for software-driven medical devices across classification, development, and post-market requirements.
IEC 62304 Software Lifecycle
Plan and track IEC 62304 software development lifecycle activities, from architecture documentation through maintenance, ensuring traceability and compliance at every stage.
Cybersecurity Compliance
Address FDA cybersecurity guidance, threat modeling requirements, and SBOM obligations with intelligence drawn from recent submissions and enforcement trends.
AI/ML Device Guidance
Navigate the evolving regulatory landscape for AI/ML-enabled devices, including predetermined change control plans, algorithm transparency, and real-world performance monitoring.
Predetermined Change Control
Build sound predetermined change control plans aligned with FDA expectations, enabling iterative algorithm improvement while maintaining regulatory compliance.
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