Contact: Dr. Mike Skalsky, Director, Emergo Australia
Darling Park, Tower 2, Level 20
201 Sussex Street
Sydney NSW 2000
Phone: +61 (0) 2 9006 1662
Fax: +61 (0) 2 9006 1010
Emergo Group assists U.S. and Australian medical device manufacturers comply with Australian TGA regulations and regulations in other markets worldwide. Services include medical device approvals, ISO 13485 and US FDA QSR quality system compliance, clinical trials, distributor qualification, in-country representation and reimbursement. We represent more than 100 medical device and IVD companies in Australia with offices in Sydney and worldwide.