Recent content by milestoneloc

Rubric Design for the AI Medical Scribe Explains how structured evaluation rubrics help assess AI medical scribe performance beyond transcription accuracy by measuring clinical completeness, documentation quality, and real-world usability.

510(k) vs De Novo vs PMA: Which FDA Pathway Fits Your AI Medical Device? Compares the FDA's three primary medical device marketing pathways 510(k), De Novo, and PMA explaining when each pathway applies, the evidence required, and how AI medical device companies can determine the appropriate...

The AI SaMD Data Playbook A practical guide for AI medical device teams preparing FDA submissions. It explains how to build regulatory-ready training datasets, ensure high-quality annotation, evaluate AI models, document traceability, manage bias, and plan post-market monitoring. It also covers...