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. Key activities undertaken by Boost Design include:

  • 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

A patient information video for the product can be viewed below:

Cancer Therapy Medical Device Design and Development

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