We Have Been Helping Medical Device Companies Since 2002.
To help manufacturers bring safe, compliant devices to the Australian market — by making the regulatory pathway clear, concise and predictable, from first submission through to ongoing compliance.
The People Behind Your Registration
George
George founded RQSolutions in 2002 and leads every engagement personally. He has taken devices across the full risk spectrum — Class I to III — through TGA registration, and acts as the named sponsor contact for the manufacturers RQSolutions represents. His work spans application strategy, ISO 13485 quality systems, audit attendance, and Prostheses List applications.
Natalie
Natalie helps manufacturers navigate TGA regulatory requirements, from submission through to approval, with a particular focus on UDI (Unique Device Identification) implementation. She brings a clinical RN background to how she reads a device's intended use and risk profile.
Backed by partners in seven countries
Where a client needs approvals beyond Australia, George and Natalie coordinate the work through vetted regulatory and quality consultancies around the world — one point of contact, wider reach.
Why sponsors choose us
Sponsor, not importer
Non-commercial Australian Sponsorship for TGA and PLAC matters — no interest in your distribution, so decisions stay yours.
One record, always current
A proprietary document management system for instant retrieval of your regulatory file when an assessor or auditor asks.
Two Decades Inside One Regulatory System
RQSolutions has worked in Australian medical-device regulation since 2002 and is listed as a TGA-recognised sponsor entity.
Let's Get Your Device To The Australian Market.
Tell us the device class and intended claims — we will map the pathway and the timeline. Free scoping call, no obligation.
Contact Us