Specialist expertise across the full medtech product lifecycle
From design through to TGA registration and market launch, RMT brings engineering, regulatory and commercial capability under one roof.
01. 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. RMT holds its own TGA ARTG registration as Legal Manufacturer – no handover required.
- Concept development and feasibility
- 3D CAD design and engineering drawings
- Design verification and validation
- Design History File (DHF) preparation
- Surgeon evaluation and feedback integration
- TGA registration as Legal Manufacturer
Instructions for Use. The use, care, cleaning and sterilisation instructions for RMT reusable surgical instruments (RMT_2501_2401 Rev 0):
02. 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
03. Contract Manufacturing
ISO 13485:2016 certified 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 and sterilisation – COMING SOON
04. 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 program design and coordination
- 3PL logistics and supply chain management
- Distribution partner identification and negotiation
- P&L modelling and commercial forecasting
05. Clinical Outcomes Follow-Up: ResolveIQ
ResolveIQ is our patient outcomes follow-up platform for surgeons and their practices. Patients enrolled in person at the clinic receive scheduled SMS and email links to validated outcome questionnaires, and surgeons see their own patients’ results over time. Data is held in Australia and surgeons own their data.