“Delivering specialist engineering, regulatory, and commercial expertise to resolve clinical challenges and bring better orthopaedic and neurosurgery technologies from concept to patient.“
What we stand for
Patient wellbeing above all
Uncompromised ethics and quality
Innovate to improve
Efficiency and sustainability
Commitment to clinician education and collaboration
Services
Collaborating with healthcare professionals to deliver comprehensive medtech solutions
Surgical Instrument Design & Manufacture
End-to-end instrument design and development for orthopaedic and neurosurgery applications. From design inputs through to design freeze, design history file, and transfer to manufacture.
- Concept development and feasibility
- 3D CAD design and engineering drawings
- Design verification and validation
- Design History File (DHF) preparation
- Surgeon evaluation & feedback integration
- TGA registration as Legal Manufacturer
Regulatory Affairs
TGA registration support and EU MDR technical documentation for medical device manufacturers. Our team holds direct experience navigating the Australian regulatory framework and supporting international submissions.
- TGA device classification and ARTG registration
- Essential Principles compliance assessment
- EU MDR technical documentation preparation
- Clinical Evaluation Report (CER) drafting
- ISO 13485 QMS implementation and gap assessment
- Post-Market Surveillance plan and report preparation
- Notified Body liaison and query management
Contract Manufacturing
ISO 13485-compliant manufacture of surgical instruments and orthopaedic implant components, from prototype through to commercial quantities with full traceability and documentation
- Prototype and first-article manufacture
- Single-use and reusable surgical instruments
- Orthopaedic implant component manufacture
- Custom and personalised device manufacture
- Incoming inspection and supplier qualification
- Non-conformance management and CAPA
- Cleanroom packaging & labelling – COMING SOON
Commercial Consulting
Strategic and operational support for medical device companies entering or expanding in the Australian orthopaedic and neurosurgery market.
- Market entry strategy and competitive analysis
- New product market introduction (NPMI)
- Surgeon KOL identification and engagement
- Clinical programme design and coordination
- 3PL logistics and supply chain management
- Distribution partner identification and negotiation
- P&L modelling and commercial forecasting
From Concept > To Clinic > To Patient
Are you ready to bring your concept to market?
Why RMT
What sets us apart
HOW WE WORK