Device Assessment & Regulatory Affairs

We collaborate with a number of university departments with access to industry standard testing facilities, which includes biomedical, chemical and mechanical engineering, as well as cutting edge analytical sciences.

The Foundation has the ability to investigate device failures, verify clinical performance claims as well as provide pre-clinical testing for regulatory approval.

Our technical team has vast experience in all aspects of national and international regulatory affairs provides clinical input into the writing and translation of product leaflets and Instructions for Use.