Medical Device Regulatory Affairs and Quality Assurance Consulting Services for the Australian TGA (Australian FDA)
Emergo Group offers medical device and IVD companies a wide array of quality assurance and regulatory compliance services through its offices in Australia, United States, Europe and Canada. Services related to Australia are shown below. To see all Emergo Group services, click here.
> Quality Assurance
ISO 13485 quality system implementation or upgrade
We have implemented and upgraded ISO 13485:2003 quality systems for hundreds of medical device companies.
ISO 13485 quality assurance (QA) outsourcing
We offer QA outsourcing on a monthly, quarterly or “As Needed” schedule and can assist with audits, document control and more.
ISO 13485 & GMP quality system and supplier audits
Our team of Certified Lead Assessors can audit your ISO 13485 and FDA GMP quality system, or conduct audits of your suppliers/subcontractors.
ISO 14971 risk management services
Let us help you adopt the ISO 14971:2007 risk management standard and integrate it with your existing ISO 13485 system.
> Regulatory Affairs & Other Services
Sponsor Representation for Australia
Emergo Asia Pacific, with offices in Sydney, is an official Sponsor to a wide variety of medical device companies.
Technical File / Technical Dossier compilation
More than 300 companies have enlisted our support to compile Technical Files for a wide range of medical devices and IVD products.
Medical device registration in Australia
The Australian Therapeutic Goods Administration (sometimes called the Australian FDA) requires all medical device manufacturers to register before selling in Australia. We can help you file the paperwork.
Distribution management in Australia
Let Emergo Asia Pacific assist you with researching, analyzing, choosing and managing distribution partners in Australia. With offices in Sydney, we know the market!
New product and technology sourcing assistance in Australia
We can help you find research partners, source new products, identify merger/acquisition opportunities or negotiate licensing agreements through our office in Sydney.
Clinical trial management consulting in Australia
Through our Sydney office, we can help determine if Australia is a suitable site for conducting clinical trials and assist in analyzing clinicians, institutions and screening CROs.
