INTRODUCTION

This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485. The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their organizations.

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.