INTRODUCTION

This 1-day Requirements Course focuses on the understanding and application of key principles and practices in accordance with ISO 13485:2016 in daily business practices and processes.

Course Objectives 

This course is designed to enhance the level of understanding of those actively utilizing and engaging in 1st Party Assessments. Our expert tutors give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485:2016 and to contribute to your continual improvement.