SaMDClinical: 전자 원자료 무결성 검증, 다기관 이중맹검 유효성 평가 및 GMLP 규격 준수 감사

SaMDClinical은 첨단 알고리즘 헬스케어 소프트웨어와 엄격한 의료기기 규제를 융합하여 임상적 안전성, 진단적 유효성 및 원활한 글로벌 시장 진입을 보장합니다.

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)

애자일 소프트웨어 개발과 의료기기 규제 연결하기

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