Profile

DR Arthur Brandwood, PhD, FRAPS

Contact Details

Bio

Regulatory Consultant with a global perspective.

Previous roles as Director of Devices Evaluation for Australian Therapeutic Goods Administration, in academic research and in commercial product development.

More than 30 years in the medical devices industry in Europe, Australia and Asia and service to ISO and the AHWP has developed a wide network and a truly global perspective on medical devices regulation and international harmonization.

A passionate educator with continuing and active involvement in University teaching and industry training.

Specialties:
Regulatory submissions, post market compliance, biomaterials, biocompatibility (active participant in ISO 10993 standards development for 20 years), ISO 14971 risk management. Strong interests in international harmonization and in medical device and IVD regulation in Asia (China, Japan, Korea, ASEAN and Australia/NZ).

Education

University of Leeds
Ph.D.
1981 To 1984

Reading University
B.Sc.
1978 To 1981

Job History

Visiting Professor in Biomedical Engineering
January 2008 - present

Founder and Principal Consultant
Sydney, Beijing, Wellington, Hong Kong
July 2000 - present

Chair, Regulatory Expert Panel, AusMedtech
November 2011 - July 2014

National Chairman - AusMedtech
October 2009 - November 2011

Director Devices Registration and Approval
January 1995 - January 2000

Senior Lecturer
January 1989 - April 1995