A structured SaMD development platform for medical software teams — manage software requirements, conduct risk analysis, track SOUP dependencies, run verification tests, and manage releases to IEC 62304 and FDA guidance.
Purpose-built modules covering the complete IEC 62304 software lifecycle — from requirements through release.
Draft, review, approve, and verify software requirements with full lifecycle tracking and traceability.
Map hazards, assign severity and probability scores, implement risk controls, and track residual risk to ISO 14971.
Catalog all Software of Unknown Provenance (SOUP) with version control, scope classification, and anomaly tracking.
Design and execute verification tests with pass/fail tracking, test protocol management, and evidence collection.
Manage software releases from Draft through Released with approval workflows and version history.
Built around IEC 62304, ISO 14971, and FDA Software guidance — the core framework for medical device software compliance.
Medical device software lifecycle
Risk management for medical devices
Software as a Medical Device guidance
Usability engineering
Set the package name, safety class (A/B/C), regulatory status, and applicable standards. The platform auto-structures your documentation framework.
Navigate requirements, risk analysis, SOUP inventory, verification tests, and releases at your own pace with structured forms and guidance.
Every release includes full traceability — from requirements through test evidence — giving you the audit trail regulators expect.
IEC 62304 · ISO 14971 · FDA Software Guidance
All five modules. Full audit trail. No setup required.
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