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Design Controls

This document shows how the repo would be managed inside an ISO 13485-style design-control process.

Design Inputs

  • The system shall assess slide-ingestion quality using deterministic thresholds.
  • The system shall create an auditable record for each ingestion decision.
  • The system shall preserve package integrity metadata for accepted uploads.
  • The system shall minimize PHI in logs and operational telemetry.
  • The system shall support CI-based verification before merge.

Design Outputs

  • Python orchestrator implementation and packaged Windows executable
  • C++ QC reference library
  • Rust attestor companion CLI
  • CI and release workflows
  • architecture, risk, and traceability documents

Design Review Gates

  • architecture review before cloud integration
  • hazard and cybersecurity review before deployment
  • verification review before release

Verification Artifacts

  • Python unit tests
  • Python CLI and web smoke tests
  • C++ metric tests
  • Rust manifest tests
  • CI and release workflow run records

Validation Strategy For A Real Program

  • bench test against known good / bad scan cohorts
  • compare accept-review-reject decisions with technologist consensus
  • trend false accepts and false rejects
  • validate deployment performance on representative edge hardware

Configuration And Change Control

  • all code and quality documents versioned together
  • PR template requires explicit review of safety, security, and verification impact
  • requirement and risk updates are mandatory when change scope affects behavior