RQ Solutions

Your Medical Devices: Approved and Authorised for Sale

Consultants at the forefront of Medical Device Registrations when Regulatory Requirements were introduced in Australia and still operating with years of experience servicing local and multinational companies.

Our network with global partners will ensure your product is approved and authorised for supply in a number of geographies around the world

What We Do

REGULATORY

We will assist with your medical device registration plans for legacy products or new technologies covering all Risk classifications

QUALITY MANAGEMENT

We set up your Quality Management System from scratch or maintain your manufacturing facilities to the latest ISO/EN standards such as ISO13485.

Our expertise in Auditing will ensure your readiness for inspections by certifying authorities

HEALTH ECONOMICS

We will assist with your company receiving the highest possible government reimbursable benefit for your implantable medical devices when supplied in Private Hospitals

SPONSORSHIP

We will be your non-commercial representative for all matters with the TGA and PLAC. You will no longer need to deal with countless importers of your product to Australia

DOCUMENT MANAGEMENT

We have developed unique capabilities for the management and instant retrieval of all documentation when required. A proven accurate, simple and non-expensive system that will minimise a largely known time waster.

GLOBAL ASSISTANCE

Our partnership in a number of geographies will ensure product approval and readiness for supply. Our services will include the appointment of carefully selected credible suppliers who can achieve your target sales plans. Please refer to our Partners page.

Client Testimonials

Our company used George as a consultant to perform registration of our medical devices in Australia. George’s deliverables were always on time, and I would highly recommend George to any medical device company that requires device registration and/or Sponsor services in Australia

Eric LamManager, Senior Regulatory Affair and Quality Manager- Helen Of Troy- Hong Kong

I have personally worked with RQSolutions for the past several years. From the first time of being introduced to George and every situation working together since then, I have seen nothing but very impressed in his knowledge, professionalism and overall service. A first-class organization and a first-class business associate – I fully validate and recommend RQSolutions

Martin ChambersVP Global Sales -Spinal Modulation – USA

Dave FernquistVP Regulatory Affairs – Glaukos Corporation – USA

I have utilised the services RQSolutions on a number of occasions. Projects have included TGA registrations, as well processing applications for product listings on the Prostheses List, to achieve medical insurance rebates. RQ has a strong understanding of the Australian regulatory landscape combined with a robust framework for working through the approvals process. George also has a strong network of contacts within the various hierarchies

Anthony AndersonGeneral Manager – Signature Spine – Australia