This course aims to give you knowledge and understanding of the regulatory environment concerning medical devices.

At the end of this course, you will know and understand materiovigilance and all related current topics to materiovigilance such as:

• the materiovigilance definition,

• the medical device definition,

• an incident definition,

• European Union regulations,

• the Field Safety Corrective Action definition,

• the role of the Medical and Healtcare Product Regulatory Agency and the United States regulations.