ISO 13485:2016 MEDICAL DEVICE MANAGEMENT SYSTEMS AWARENESS TRAINING

Understand the fundamentals of ISO 13485

Understand the fundamentals of ISO 13485

LIVE VIRTUAL TRAINING SCHEDULE 

  • 30th May 2022: ISO 13485:2016 Medical Device Management System Awareness Training
    9 am to 6 pm SGT | 1 Day
  • 28th Jul 2022: ISO 13485:2016 Medical Device Management System Awareness Training
    9 am to 6 pm SGT | 1 Day
  • 29th Sep 2022: ISO 13485:2016 Medical Device Management System Awareness Training
    9 am to 6 pm SGT | 1 Day
  • 29th Nov 2022: ISO 13485:2016 Medical Device Management System Awareness Training
    9 am to 6 pm SGT | 1 Day

ABOUT THE COURSE

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 recognized 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.

This training is to highlight the significant changes that affect registrants within the scheme, to help organisations understand some of the changes and how the changes may impact them.

Duration: 1 - day course

WHAT WILL YOU LEARN FROM THE COURSE?

At the end of this course, participants will be able to:

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

Topics to be covered in this course include:

Introduction to Quality Management System
Overview of ISO 13485:2016 requirements
Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements

WHAT IS THE COURSE METHODOLOGY?

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

WHO SHOULD TAKE THE COURSE?

This course is specially designed for:

Quality and Regulatory Managers/Supervisors
Product Designers
Management Representatives and Consultants

Prerequisite: None 

WHO IS THE COURSE ADVISOR?

The course content and structure are designed by the domain experts from TÜV SÜD.

With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.

 

  • What are the benefits of enrolling in this course?
    • World-class training – by learning from TÜV SÜD’s industry experts and training specialists

    • Interactive learning style – with interactive formats such as lectures, illustrations and simulations are used

    • Networking opportunity – where you can meet and build network with like-minded individuals at our instructor-led training

    • Gain a competitive edge – by getting trained by experts known in the fields of safety, security and sustainability

 

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