MedicalSoftwareAI：FDA PCCPプロトコル、自動臨床再検証テスト、ISO 14971リスクヘッジ

MedicalSoftwareAIは、ISO 13485準拠の機械学習フレームワーク、マルチモーダル医用ビジョントランスフォーマー、およびFDA 510(k)、De Novo、PMA申請用の自動化規制申請ドキュメント生成ツールを提供します。

MedicalSoftwareAI Clinical Diagnostics & Regulatory Clearance Pipeline

DICOM image ingest, vision transformer inference, and automated 510(k) evidence compilation

Central System: Clinical Vision Kernel - ISO 13485 Diagnostic Core

Clinical IoMT Nodes

  • DICOM / PACS Ingestion
  • Vision Transformer Backbone
  • Clinical Finding Segmenter
  • Biostatistical Profiler
  • 510(k) Dossier Compiler

Architectural Layers & Regulatory Standards

  • Medical Imaging Ingest Plane (DICOM WADO-RS / HL7 FHIR ImagingStudy): Streaming full-resolution 3D DICOM volumes (CT/MRI) directly from hospital PACS archives.
  • Multi-Modal AI Inference Engine (Vision Transformers (ViT) & SwinUNETR Backbones): Executing 3D volumetric semantic segmentation for oncology, stroke, and cardiovascular pathology.
  • Clinical Validation & Grounding (Multi-Reader Multi-Case (MRMC) ROC Analysis): Validating algorithmic diagnostic sensitivity and specificity against expert radiologist ground truth.
  • Regulatory Dossier Automation (Automated Substantial Equivalence Compiler): Compiling technical files, hazard matrices, and clinical performance comparisons against predicate devices.

Key Metrics: > 0.98 (AUC-ROC Diagnostic Performance) | < 1.8 s (3D CT Volumetric Inference) | ISO 13485 (Quality Management System) | 510(k) Ready (Automated Predicate Matching)

臨床AI診断、マルチモーダル医療Vision Transformer、ISO 13485とFDA 510(k)市販前臨床承認

Authoritative technical engineering reference for clinical ai diagnostics, multi-modal medical vision transformers, iso 13485 & fda 510(k) premarket clinical clearance in FDA Premarket submissions, EU MDR, IEC 62304 Class C software lifecycle, ISO 13485 quality systems, and IoMT zero-trust interoperability.

Core Engineering Areas

Technical Articles

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