Radiology Medical Device.

Breathe Well is a Class I device designed to assist cancer radiation patients better control their breathing in order to achieve improved treatment.


  • Review of regulatory strategy and existing TGA/FDA documentation prior to submission
  • Translation of product features into testable requirements
  • Development of basic verification and validation test procedures
  • Development of single-fault risk assessments and mitigations
  • Manufacturing strategy planning
  • Compliance and certification test support
  • Engineering support
  • General start-up guidance and advice
Contact Us

Unit 2, 47 John Street Leichhardt, NSW, Australia