- 1
Is your software a medical device?
The 3-step litmus test, the DSF draft definition, and the edge cases that trip teams up.
- 2
IMDRF risk categorization
How the IMDRF SaMD risk categories map to FDA classes and review pathways.
- 3
IEC 62304 software lifecycle
Aligning software lifecycle with ISO 14971 risk in one coherent SaMD program.
- 4
PCCPs for AI-enabled devices
What goes in your PCCP, what FDA reviews, and how to keep iterating after clearance.
- 5
Cybersecurity per FDA §524B
SBOM, threat modeling, secure design, and the eSTAR cybersecurity section.
- 6
Which pathway for SaMD?
When SaMD goes 510(k), when De Novo, when PMA - with worked examples.
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Founder Track
From device idea to documented FDA strategy
RA Lead Track
Standardize how your team writes 510(k)s, risk files, and design history files
International Track
Enter the US market from abroad. The whole pathway, in plain English.
Post-Market Track
Your device is on the market. Stay compliant. Survive inspections. Avoid recalls.