My expertise is the regulation of medical devices and in-vitro diagnostic medical devices (IVDs), especially the European medical device directives.

I have provided expert opinion on the clinical investigation of coronary stents in a US case and, most recently, in a case involving mesh implants used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in the Federal Court of Australia.

The Australian case involved providing opinion on the manufacturer’s compliance to the European regulatory requirements—particularly in terms of risk management, clinical evaluation, clinical investigation and post-market surveillance.