GI Therapies

Ms Gemma de Plater

Quality Assurance & Regulatory Affairs Manager

Gemma has over 17 years’ experience in the medical devices industry, having worked for medical device manufacturers and both product development and QA/RA consultancies. Her experience ranges from complex electromedical equipment, active implantable devices and home use devices.

She has led activities in product design, verification and validation, clinical trial product distribution and management, quality systems development and implementation, and regulatory strategy development and compliance in Australian and International markets.

Gemma is a qualified industrial designer with experience in project management, risk management and manufacturing technologies and an in-depth knowledge of ISO 13485:2016 and the US FDA 21 CFR 820 Quality System Regulations.