ISO 13485:2016 MEDICAL DEVICE MANAGEMENT SYSTEMS INTERNAL AUDITOR TRAINING

Discover the changes in ISO 13485:2016 and boost your audit capabilities

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 two-day training is to highlight the significant changes that affect registrants within the scheme, to help organisations understand some of the changes, how the changes may impact them, and how to audit against the revised ISO 13485:2016 standard.

Duration: 2 - 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
Acquire the skills to take on the position of an internal medical services auditor in the company

Topics to be covered in this course include:

Day 1

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

Day 2

Audit planning and preparation
Audit execution
Non-conformity reporting
Closing meeting
Audit report preparation
Audit follow-up

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
Internal Auditors 
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

  • FAQs
    1. How do I enroll for the course?
      To enroll, click here and fill out the form accordingly.
    2. What is the course methodology?
      Participants will learn through role plays, case studies, group exercises, scenarios and discussions.
    3. Are there any tests in the middle of the course?
      There are no in-between assessments, but case studies will be included in the course.
    4. Can I get a refund if I cancel my enrollment?
      Yes, please contact us at training.sg@tuvsud.com for more details. Terms and conditions apply.
    5. Can I also attend E-learning courses on top of attending the instructor-led course?
      Yes, you can register to any e-learning courses. If you have special requirements, please contact us at training.sg@tuvsud.com  and we can customise a suitable package for you.
    6. Upon completion of the course, would I get a certificate for completion?
      Yes, you will receive a certificate of completion at the end of the course.
    7. Who developed the course and what are their qualifications?
      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. The experts also undergo relevant upskilling programmes, benefitting from TÜV SÜD’s 150 years of expertise and global heritage.

    To contact someone from TÜV SÜD, you may email us at training.sg@tuvsud.com 

    To know more about TÜV SÜD, please click here.

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