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Lumina Medtech provides integrated commercial, regulatory and quality services to support medical technology companies entering and growing in the Australian market.
Our difference lies in how these capabilities work together — commercial strategy informed by regulatory reality, and compliance designed to support adoption and growth
Our Services
1
Market Opportunity & Strategy
Helping you decide whether, when and how to enter Australia.
- Market opportunity assessment - Competitive and clinical landscape analysis
- Reimbursement and funding considerations - Go-to-market and launch strategy
2
Commercialisation & Distribution
Turning strategy into market traction.
- Launch planning and execution - Distribution and channel strategy - Clinical education and adoption - Market development and growth initiatives
3
Regulatory, Quality & Clinical Enablement
Strong foundations that support long-term success.
- Regulatory pathway guidance and TGA submissions - Australian Sponsor services - Post-market surveillance and change management - Quality management systems (ISO 13485, 21 CFR 820 alignment) - Clinical evaluation reports and clinical investigation support
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