7-Part Series
SaMD Engineering
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
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
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
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.
HIPAA Compliant AWS Architecture for Medical Device Software
HIPAA compliant AWS architecture for SaMD requires more than signing a BAA. How we built ContourCompanion on ECS with GPU instances, PHI controls, and audit trails.
Infrastructure as Code for Medical Devices: IQ OQ PQ with AWS CDK
Infrastructure as code replaces manual IQ OQ PQ for medical devices. How we used AWS CDK and cdk-nag to automate GxP qualification for ContourCompanion.
Design Controls for Medical Devices: 21 CFR 820.30 in Practice
Design controls under 21 CFR 820.30 require a design history file with full traceability. How we ran design controls for a Class II AI SaMD using agile sprints.