FDA SaMD Classification for Digital Health
What FDA SaMD Classification means for Digital Health organizations — and how we implement it at the architecture level.
FDA SaMD Classification in Digital Health environments carries requirements that go beyond the framework's general provisions. The specific operations of Digital Health organizations — their data processing scale, their regulatory relationships, and their operational dependencies — create compliance obligations that engineering teams must address at the architecture level. Generic FDA SaMD Classification compliance that ignores the Digital Health context will produce a system that passes audit by a framework-generalist but fails review by an industry-specialist examiner.
Our teams deploy in Digital Health environments with FDA SaMD Classification compliance built into the architecture from the first design decision. The compliance controls are not a layer added to an existing system — they are implemented as first-class components that generate evidence continuously as the system operates. The result is a system that is compliant on deployment day, remains compliant as it evolves, and produces audit evidence without manual assembly.
FDA SaMD Classification compliance documentation maintained as live system artifacts, not annual documentation projects
Access controls that satisfy FDA SaMD Classification requirements for Digital Health data handling
Audit logging that generates evidence meeting FDA SaMD Classification audit standards in Digital Health regulatory contexts
Incident response procedures aligned to FDA SaMD Classification notification and reporting timelines
Third-party vendor compliance documentation satisfying FDA SaMD Classification supply chain requirements
We implement FDA SaMD Classification compliance for Digital Health clients by mapping the framework's requirements to the specific operational context of Digital Health organizations before writing application code. Controls are implemented through infrastructure-as-code, enforced automatically by ALICE at every commit, and documented through automated evidence generation pipelines. The result is a FDA SaMD Classification-compliant Digital Health system delivered on a fixed-price timeline.
Ready to build FDA SaMD Classification compliance into your Digital Health system?
We build compliance architecture for Digital Health organizations — FDA SaMD Classification and the full Digital Health compliance landscape — from the first infrastructure decision. Fixed price. Production delivery. No discovery phase.