Quality & Compliance

Regulatory & Quality

Transparency about our current regulatory status, quality system approach, and clinical evidence strategy.

Current Status
Not cleared or approved by FDA, TGA, or other regulatory bodies

Current Regulatory Status

FDA 510(k) Clearance
Not submitted
CE Mark (EU MDR)
Not submitted
TGA Registration (Australia)
Not submitted
Health Canada License
Not submitted

Currently Available For:

  • Research and development collaborations
  • Retrospective data analysis
  • Pre-submission regulatory engagement planning
  • Pilot deployments under appropriate research protocols
  • OEM integration feasibility assessments

Regulatory Strategy

Phase 1

Partner Engagement

Identify clinical partners and use cases

Phase 2

Evidence Generation

Prospective validation studies

Phase 3

Regulatory Submission

Initial market clearance

Phase 4

Market Expansion

Additional geographies and indications

Timeline and approach subject to change based on partner requirements and regulatory guidance.

Quality Management System

Our development follows medical device quality principles. Formal certification in progress.

Software Development

IEC 62304 Alignment

  • Risk-based software classification
  • Requirements traceability
  • Design and code review processes
  • Verification and validation protocols

Risk Management

ISO 14971 Alignment

  • Hazard analysis and risk assessment
  • Risk control measures documented
  • Residual risk evaluation
  • Post-market surveillance planning

Clinical Evidence

MEDDEV / MDR Approach

  • Retrospective evaluation completed
  • Prospective validation planned
  • Clinical utility studies designed
  • Literature review maintained

Cybersecurity

IEC 81001-5-1 Principles

  • Security requirements in SDLC
  • Threat modeling conducted
  • Vulnerability management process
  • Penetration testing (details under NDA)

Regulatory & Quality Discussion

We welcome discussions with regulatory and clinical affairs teams evaluating Aranga for their specific use cases. Our approach emphasizes transparency, partnership in evidence generation, and alignment with partner regulatory strategies.

Schedule Regulatory Discussion