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Evidence & Quality

Built on Evidence

Peer-reviewed publications, institutional validation, and rigorous quality standards. Transparent evidence for procurement confidence.

Peer-Reviewed Publications

Clinical validation and accuracy studies from independent institutions.

In vivo skin dose measurement using MOSkin detectors in tangential breast radiotherapy
Wilson R., Lee S., et al.
 • Physica Medica
 •2016
Clinical study measuring skin dose in tangential breast radiotherapy, demonstrating reliable surface dose monitoring in routine clinical conditions.

peer-reviewed

Photon
Application of MOSkin detector for in vivo dosimetry on total skin electron therapy (TSET)
Petasecca M., Cutajar D., Rosenfeld A., et al.
 • Biomedical Physics & Engineering Express
 •2017
Evaluation of MOSkin performance for skin dose measurement in total skin electron therapy, showing agreement with established dosimetry methods.

peer-reviewed

Electron
Dose build-up characteristics with eXaSkin bolus during 6 MV radiotherapy: MOSkin dosimetry results
Benedict S., Cutajar D., Rosenfeld A., et al.
 • IOP Science Journal of Physics: Conference Series
 •2019
Assessment of surface and build-up region dose using bolus materials, confirming MOSkin precision in high-gradient dose regions near the skin.

peer-reviewed

Photon

Medical Device Disclaimer:

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.

Evidence for Procurement

Documentation packages designed to support institutional review and approval processes.

Technical Dossier

Complete technical specifications, validation data, and compatibility information.

Clinical Evidence

Bibliography of peer-reviewed studies.

Questions About Evidence?

Our team can provide additional documentation and answer technical questions to support your evaluation.