Clinical trials for medical devices

Clinical trials for medical devices

Clinical trials, also referred to as clinical investigations or clinical studies, are systematic investigations in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of a medical device (definition from international standard ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice).

Clinical trials in Australia

 

Clinical Investigations Research Agreements

Clinical Trials regulatory framework

 

Advertising of clinical trials