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SaMD Engineering
4-Part Series

SaMD Engineering

Software as a medical device (SaMD) means full regulatory burden with no hardware to hide behind. How we built and FDA-cleared an AI radiotherapy SaMD on AWS.

What Is SaMD? Software as a Medical Device Explained · FDA Pathways for SaMD · IEC 62304 in Practice · ISO 14971 Risk Management for SaMD

Document AI
1-Part Series

Document AI

Every vendor demo hits 95% accuracy. Deploy on real documents and it drops to 60%. Here's what breaks, why, and the hybrid pipeline that fixes it.

Document Processing in Production

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