ISO 13485:2016 Overview

Who is this course for?

This course is designed for professionals aiming to understand and implement the requirements of the ISO 13485:2016 standard, which specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is ideal for individuals involved in the design, production, installation, or servicing of medical devices and those seeking to ensure their organization remains compliant with the standard.

Whether you are looking to enhance your current skill set, are new to the medical device sector, or need a thorough refresher on the standard's prerequisites, this course offers detailed insights that will help you navigate the complexities of compliance in the medical device industry. The content is structured to provide not only an overview but also practical understanding and readiness to apply the knowledge in real-world settings.

Target audience:

• Quality assurance and control professionals in the medical device field

• Regulatory affairs managers

• Product designers and developers of medical devices

• Production and operations staff working with medical devices

• Audit and compliance personnel focusing on medical device standards

• Project managers overseeing medical device manufacturing projects