Description: During this session we will discuss what are the characteristics of a strong Quality Management System and how it can support manufacturers' regulatory strategy. We will go through processes and regulatory regions examples to illustrate the topic. The audience will be invited to share their experience to add on to the discussed examples.
Learning Objectives:
Identify the key elements of an ISO 13485 based QMS that are the most impactful for regulatory strategy
Use of existing global harmonized tools to strengthen a QMS
