SaMDClinical：電子的原資料検証、二重盲検バリデーション、GMLP品質監査自動化

SaMDClinicalは、高度なアルゴリズム医療ソフトウェアと厳格な医療機器規制を統合し、臨床的安全性、診断の有効性、円滑なグローバル市場参入を確実にします。

SaMD Lifecycle & Clinical Validation Architecture

Traceability Matrix and Regulatory Dossier Compilation

Central System: Clinical Validation Kernel - IEC 62304 Engine

Clinical IoMT Nodes

  • Clinical Evidence Engine
  • Hazard Analysis DB
  • Static Code Verification
  • Algorithm Audit Log
  • Biostatistical Validator

Architectural Layers & Regulatory Standards

  • Requirements & Safety Classification (IEC 62304:2015 Clause 4 / IMDRF SaMD Framework): Decomposing clinical claims into architectural software safety classes A, B, or C under IEC 62304.
  • Architectural Hazard Mitigation (ISO 14971 Risk Controls / MISRA C:2012 Guidelines): Formal fault-tree analysis ensuring memory safety, watchdog supervision, and fail-safe defaults.
  • Verification & Static Analysis (DO-178C Level A / ISO 26262 ASIL-D Borrowed Rigor): 100% statement, branch, and MC/DC code coverage with automated memory leak and overflow proofs.
  • Clinical Performance Evaluation (EU MDR Annex XIV / FDA Clinical Evaluation Guidance): Biostatistical validation against multi-center clinical datasets establishing diagnostic sensitivity.

Key Metrics: Class C (Highest IEC 62304 Risk Category) | 100% (Bidirectional Requirement Traceability) | MC/DC (Modified Condition Decision Coverage) | ISO 13485 (QMS Audit Trail Conformance)

アジャイルソフトウェア開発と医療機器規制を橋渡しする

Developing medical algorithms requires navigating strict regulatory boundaries. SaMDClinical formalizes software safety classification, unit verification, and clinical performance evaluation into a continuous automated CI/CD pipeline.

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications