Module 15 2022

20/05/2022

Agenda

• Types of clinical studies • Implication of MDR • ISO14155:2020 • Safety Reporting (MDR, MDCG & ISO) • Clinical strategy notification requirements. The role of the clinical team and regulatory governance • Data Protection • UK Submission Process – Post Brexit

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

3

Types of Clinical Studies

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

4

2