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SaMD Risk Categories (IMDRF): What They Mean & How They Relate to FDA Review
IMDRF categorizes SaMD risk (I–IV) by crossing significance of information (inform, drive, treat/diagnose) with the condition’s...
May 133 min read
Device Software Function (DSF): FDA’s 2025 AI Draft Definition
“For purposes of this guidance, FDA refers to a software function that meets the definition of a device as a ‘device software function.’”...
May 83 min read
What Counts as SaMD? FDA Definition in Plain English
Software as a Medical Device (SaMD) = software that has a medical purpose and performs that purpose without being part of a hardware...
May 74 min read
FDA Guide to AI/ML SaMD: Pathways, PCCP, and Evidence
FDA regulates AI and ML in SaMD using existing device pathways plus AI-specific expectations. Key elements include the 2025 PCCP final...
Oct 29, 20245 min read
FDA's Software as a Medical Device (SaMD) Explained
As technology continues to transform healthcare, Software as a Medical Device (SaMD) has become crucial in diagnostics, treatment, and...
Oct 25, 20245 min read
How AI is Transforming Regulatory Compliance
Navigating the complex waters of regulatory compliance has long been a challenge for businesses across the globe. As the volume and...
Jul 3, 20245 min read
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