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📋 AI Software Version Control Clinical Validation Simulator

Clinical validation of a new version of AI software before its implementation.

AI/ML SaMD Regulatory Pathway2DModerate60 FPS
ai-software-version-clinical-validation-simulator ↗ Open standalone

A New Build Enters the Lifecycle

Every candidate version starts here, regardless of size.

  • 3: Change types seen (bug fix, minor update, retrain)
  • 1: Entry point (single intake gate)
  • 0: Unvalidated deploys (none allowed to skip review)
  • All: Versions tracked (full build history logged)

Why every change enters the same gate

No version, however small, bypasses intake review.

Does This Touch Clinical Decision Logic?

Classification splits changes into non-clinical vs clinical-impact.

  • 2: Classification axes (significance, decision-logic impact)
  • UI, perf, logging: Non-clinical examples (no decision-logic change)
  • Thresholds, model weights: Clinical examples (alters output behavior)
  • High cost: Misclassification risk (under-validation risk)

Sorting signal from noise

A UI tweak and a retrain look similar in a diff, not in risk.

Scope Scales to Classification

Minor changes get streamlined checks; major ones get full validation.

  • 3: Streamlined checkpoints (regression-only track)
  • 6: Moderate checkpoints (expanded regression + subset)
  • 10: Full checkpoints (full clinical validation track)
  • Review board: Scope decision owner (sets required track)

Proportional, not maximal, validation

Over-testing trivial fixes wastes cycles; under-testing major ones risks harm.

Checkpoints Run at the Determined Scope

Each track runs its checkpoints until all gates turn green.

  • 2: Checkpoint states (pending, passed)
  • 1 active: Track parallelism (only chosen track runs)
  • Full track only: New evidence needed (clinical evidence sometimes required)
  • Sequential: Gate order (checkpoints clear in order)

Turning checkpoints green

Every checkpoint on the active track must pass before advancing.

Deploy Only After Clearing the Bar

Skipping proportional validation risks shipping unvalidated clinical change.

  • 2: Deploy states (pending, approved)
  • All checkpoints green: Approval condition (on the active track)
  • Available: Rollback path (if post-deploy signal regresses)
  • Retained: Audit trail (classification + test evidence kept)

The proportional bar is the safeguard

Deployment readiness reflects evidence, not just build completion.

Scaling validation to change impact is what keeps deployment fast for trivial fixes and rigorous for clinically-meaningful ones.
⚙ Under the hood

Clinical validation of a new version of AI software before its implementation.

CanvasBiomedicine

2D · HTML5 Canvas 2D · 60 FPS target · runs fully client-side, no install

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