SaMDApp: Bioseñales rPPG por Cámara, Biomarcadores Acústicos y Ciberseguridad FDA

SaMDApp ofrece marcos móviles multiplataforma, protocolos de ingeniería de usabilidad IEC 62366-1 e integración de sensores médicos Bluetooth certificados para terapias digitales (DTx) y apps médicas móviles Clase IIa/IIb.

SaMDApp Mobile Medical Architecture & Clinical Adherence Topology

Secure mobile sandbox, BLE biosensor manager, and clinical adherence feedback engine

Central System: Mobile SaMD Core - IEC 62366-1 Enclave

Clinical IoMT Nodes

  • Encrypted Mobile Vault
  • BLE Medical Gateway
  • Clinical Adherence Engine
  • Prescription Access Gate
  • EHR Telemetry Sync

Architectural Layers & Regulatory Standards

  • Mobile Operating System Sandbox (iOS Secure Enclave / Android KeyStore / SQLCipher): Encrypting all local patient health data with hardware-backed AES-256 keys.
  • Medical Sensor Interconnect (Bluetooth Low Energy (BLE) Medical Profiles): Ingesting continuous blood glucose (CGM), blood pressure, and pulse oximetry streams.
  • Clinical Usability & Human Factors (IEC 62366-1 Usability Engineering Process): Eliminating user interface ambiguities, medication dosing errors, and cognitive confusion.
  • Prescription & Telehealth Bridge (SMART-on-FHIR App Launch / RESTful API): Unlocking digital therapeutic modules via validated pharmacy e-prescriptions.

Key Metrics: Class IIa/IIb (EU MDR Mobile Classification) | IEC 62366 (Human Factors Usability) | < 0.01% (User Interface Error Rate) | 100% (Local Encrypted Storage)

Aplicaciones Móviles SaMD, UI/UX Clínica Clase IIa/IIb, Ingeniería de Usabilidad IEC 62366 y Ciclos de Adherencia del Paciente

Referencia técnica de ingeniería autorizada para mobile samd applications, class iia/iib clinical ui/ux, iec 62366 usability engineering & patient adherence loops en regulaciones FDA 510(k), EU MDR, ciclo de vida IEC 62304 Clase C e interoperabilidad IoMT.

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications