← All engineering posts

4-Part Series

SaMD Engineering

What Is SaMD? Software as a Medical Device Explained
Part 1

What Is SaMD? Software as a Medical Device Explained

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.

FDA Pathways for SaMD: 510(k) vs De Novo vs PMA
Part 2

FDA Pathways for SaMD: 510(k) vs De Novo vs PMA

How to choose between 510(k), De Novo, and PMA for your SaMD. Real costs, timelines, and the pathway decision we made for an AI radiotherapy tool.

IEC 62304 in Practice: Medical Device Software Without the Waterfall
Part 3

IEC 62304 in Practice: Medical Device Software Without the Waterfall

IEC 62304 doesn't mandate waterfall. How we ran agile sprints for a Class C SaMD and satisfied every lifecycle requirement with less documentation, not more.

ISO 14971 Risk Management for SaMD: What FDA Reviewers Read
Part 4

ISO 14971 Risk Management for SaMD: What FDA Reviewers Read

ISO 14971 requires a risk management file for every medical device. How we structured one for a Class C AI SaMD with dozens of hazards and full traceability.