What We Do | Lumina Medtech

What We Do

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.

Core Service Areas

Market Opportunity & Strategy

Helping you decide whether, when and how to enter Australia.

Market opportunity assessment
Competitive landscape analysis
Pricing & reimbursement strategy
Go-to-market & launch strategy

Commercialisation & Distribution

Direct sales & marketing execution
Key Opinion Leader (KOL) engagement
Hospital approvals & procurement
Inventory management & logistics
Product launch & market development

Regulatory, Quality & Clinical Enablement

TGA registration & sponsorship
ISO 13485 & Quality System management
Post-market surveillance & reporting
Clinical trial support & coordination
EU MDR/IVDR to TGA transition

Not sure which capabilities you need right now?

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