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

RQsolutions

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 Partners

Read more about our Partners here

Contact Us

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