TCM-1 Intelligence Stack
Combining on-device signal processing, closed-loop thermal algorithms, and secure BLE 5.0 data transmission within our ISO 13485 quality management framework.
On-Device Signal Control
Executes local thermal adjustments directly via embedded firmware. Evaluates operational safety boundaries continuously without dependence on network connectivity.
Certified Quality Framework
Developed under DMT's audited ISO 13485, TGA Q00557, and MDSAP certified Quality Management System, maintaining full traceability and Design History File (DHF) compliance.
AI Device Management SaaS
Co-developed with university research partners. BLE 5.0 telemetry powers encrypted device-to-app sync, cohort analytics, and OTA platform updates for clinical partners.
Engineered Depth, Delivered
Four core disciplines behind our cartridge and main-unit designs — characterized, validated and documented together with our lab network.
Fluid Dynamics & Porous Media
Characterization of wicking media and fluid-transport behavior for consistent, repeatable delivery across operating conditions.
DetailsThermal Management
Precision thermal profiling and power-curve development, validated across temperature and usage patterns.
DetailsAirflow & Pressure Balance
Airflow-path and pressure-balance engineering tuned for gentle, consistent vapor delivery and output stability.
DetailsSeal Integrity & Materials
Material compatibility and seal engineering verified for long-term reliability and stability.
DetailsMechanism-level engineering models shared under NDA with qualified partners.
System Architecture
Closed-loop data flow designed for scalable medtech deployment.
Designed for the Next Generation
New cartridge and main-unit designs — built around an on-device AI model — are being implemented for future TGA, NMPA and MDA regulatory testing.
TGA — Australia
AI-driven cartridge and main-unit designs prepared for evaluation under TGA conformity pathways — building on our issued Q00557 certification and ISO 13485 quality foundation.
Foundation: Q00557 IssuedNMPA — China
Pursuing Class II registration pathway with partners for future domestic deployment of next-generation designs.
Pathway: In ProgressMDA — Malaysia
New cartridge and main-unit submissions aligned with Medical Device Authority requirements for the Malaysian market.
Registration: PlannedWhat the AI-Driven Design Must Prove
New testing requirements for the next-generation AI-based design — prepared for future TGA conformity assessment.
Air Pump Safety & Performance
Pressure and flow validation, independent fail-safe cutoff verification, endurance, leak and overpressure testing under ISO 14971 risk management.
DetailsAI Software Compliance
IEC 62304 lifecycle documentation, IMDRF SaMD risk framework, ML model validation with dataset governance and locked-model declaration.
DetailsElectrical Safety & EMC
IEC 60601-1 / 60601-1-2 conformance, battery safety and applied-part testing under TGA Essential Principle 12.
DetailsClinical Evaluation
ISO 14155-aligned clinical evidence to satisfy TGA Essential Principle 14, supported by university research partnership data.
DetailsCybersecurity & Data Privacy
IEC 81001-5-1 security lifecycle, encrypted telemetry, and Australian Privacy Principles compliance for SaaS data (EP12.1).
DetailsMaterials & Usability
ISO 10993 biocompatibility, ISO 18562 gas-path testing, and IEC 62366-1 usability engineering (EP7 / EP9).
DetailsPlanned evaluation program — not yet submitted to any regulator.