SaMDClinical: Электронная верификация источников, двойная слепая валидация и аудит GMLP

SaMDClinical соединяет алгоритмическое медицинское ПО и строгие регуляторные нормы для медизделий, гарантируя клиническую безопасность, диагностическую эффективность и беспрепятственный выход на глобальные рынки.

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)

Соединение гибкой разработки ПО с регулированием медицинских устройств

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