ISO 13485:2016 Awareness (8 hrs)

Course Code: ISO13485-ATMD-01

In the pursuit of continual improvement, organisations are constantly embarking on the journey to strengthen its quality management systems and processes with the aim to produce high customer loyalty, satisfaction and build long term partnerships with them.

To keep quality management system standards relevant to the community of users, ISO 13485, the internationally recognised quality management system standard for medical devices industry, underwent major changes by the Standard Body and the revised medical standard ISO 13485:2016 was published on February 25, 2016. Participants will understand how the changes impact their organisations.

  • Understand the requirements of ISO13485:2016 for medical products and related services
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
  • Introduction to Quality Management System
  • Overview of ISO 13485:2016 requirements
  • Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements

Participants will learn through lectures, case studies, group exercises and discussions.

This course is suitable for:

  • Medical device manufacturer and vendor personnel who will be involved in the launch of management systems or updating of the current management system
  • Quality management officers (QMOs)
  • Product managers / designers
  • Regulatory affairs personnel
  • Consultants in the medical device industry

Duration : 1 day (8 hrs)
Time : 9:00am – 6:00pm

Course Fee : $450.00
Nett Fee Incl. 7% GST : $481.50

(A course in partnership with TÜV SÜD)

Key Benefits
  • Understand the requirements of ISO13485:2016 for medical products and related services
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
Course Contents
  • Introduction to Quality Management System
  • Overview of ISO 13485:2016 requirements
  • Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements
Learning Methodology

Participants will learn through lectures, case studies, group exercises and discussions.

Who Should Attend

This course is suitable for:

  • Medical device manufacturer and vendor personnel who will be involved in the launch of management systems or updating of the current management system
  • Quality management officers (QMOs)
  • Product managers / designers
  • Regulatory affairs personnel
  • Consultants in the medical device industry
Course Details

Duration : 1 day (8 hrs)
Time : 9:00am – 6:00pm

Course Fee : $450.00
Nett Fee Incl. 7% GST : $481.50

(A course in partnership with TÜV SÜD)

Course Application

Details Registration
February 27, 2020 - February 27, 2020 (9:00 am - 6:00 pm) Closed