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Duration

1-Day

9:00 AM - 5:30 PM EST

  

Course Fee

US$795.00 per attendee (for courses held in US)

CAD$795.00 per attendee (for courses held in Canada)

   

Certificates

Participants will receive the below certificates at the conclusion of the course. All certificates are issued by TUV USA.

Certificate of Attendance to the attendant who participates in the entire course.

Course Objective

This one-day ISO 13485:2016 Understanding the Requirements Course will provide you information and in-depth knowledge of the ISO 13485:2016 Standard. Through lectures, discussion and workshops, we will review the requirements of ISO 13485:2016 Standard in detail and equip the attendees with the necessary skills to design and implement your medical device quality management system based on ISO 13485:2016 requirements.

  

Course Content

During this course, the basic information on medical device quality management system of ISO 13485:2016 Standard will be discussed in two modules.

Module 1: In this module, you will learn about the basic information on medical device related quality management system.

Module 2: In this module, you will learn the requirements of ISO 13485:2016 Standard from Clause 1 to 8 including Quality Management System, Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement.

  

Who should attend?

  • Personnel in an organization with responsibility for designing and implementing your medical device quality management system based on ISO 13485:2016 Standard.
  • Departmental managers and supervisory staff new to ISO 13485:2016 Standard.
  • Top management in an organization who would like to know more about ISO 13485:2016 Standard and their roles and responsibilities in a medical device quality management system based on ISO 13485:2016 Standard.

  

Pre-requisites

The attendee shall have some basic knowledge of medical device industry.

   

Learning Outcomes

Attendees will achieve the following learning outcomes after completing the course:

  • Understanding the basic information on medical device quality management system
  • Understanding and applying the ISO 13485:2016 requirements to your own medical device quality management system

  

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