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.
Activities.
- 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
