MOSkin is intended to support clinician decision-making through real-time dose verification. Clinicians are responsible for all treatment decisions. Performance data should be evaluated in conjunction with institutional protocols and regulatory guidance.
Grants & Recognition
Institutional support and industry recognition for innovation in patient safety.
Australian Innovation Grant Program
Australian Government • 2024
AU$1.046m
Commercialization support for MOSkin technology development, manufacture, and clinical validation studies.
Good Design Award
Good Design Australia • 2025
Recognition
Australia’s highest international design accolade, recognized by the World Design Organization (WDO).
Standards & Compliance
Manufacturing and quality processes mapped to international medical device standards.
ISO 13485:2016
Medical devices — Quality management systems
Certified
Full QMS certification for design, manufacture, and distribution of medical devices.
IEC 60601-1
Medical electrical equipment — General requirements for basic safety
Certified
Electrical safety testing completed for Hub and accessories.
IEC 62304
Medical device software — Software life cycle processes
Certified
Software development and maintenance processes for iPad application.
ISO 14971
Medical devices — Application of risk management
Certified
Risk management file maintained throughout product lifecycle.
ISO 13485:2016 Certificate
MOSkin is manufactured under a certified quality management system. Full certification documentation and manufacturing site audit reports are available for procurement review.