Anne Saletti-Hayes

Senior Consultant

About Anne,

Anne is a Regulatory Affairs professional with a broad range of medical device (including software) and in vitro device (IVD) experience. Anne has a wealth of experience in regulatory activities including pre-market processes including marketing authorisation submissions and post-market processes such as regulatory file maintenance, recalls and complaints within Australia, New Zealand and the United States. Anne has experience in applying the principles and requirements of ISO 13485 (Medical Devices), ISO 14971 (Risk) and IEC 62304 (Software).