MEDICAL DEVICE MANAGEMENT SYSTEMS TRAINING

Establish an efficient quality management system for medical devices with ISO 13485

Establish an efficient quality management system for medical devices with ISO 13485

ABOUT THE MEDICAL DEVICE MANAGEMENT SYSTEMS COURSES

Considered as one of the most highly regulated sector in the world, the medical devices industry must demonstrate compliance with regulatory and product requirements to ensure safety and performance of medical devices produced.

ISO 13485:2016 Medical Device Management Systems (MDMS) is the international standard that sets out the requirements for Quality Management System standard specifically for the medical devices industry. It encompasses aspects of the ISO 9001 standard, plus additional industry-specific medical device requirements. It is designed to be used by organisations throughout the lifecycle of a medical device and it also covers storage, distribution, installation and servicing, and the provision of associated services.

The MDMS courses will provide the knowledge and understanding of the requirements of ISO 13485:2016 to help organisations increase their competitive advantage in the medical device industry.

WHAT WILL YOU LEARN FROM THE COURSES?

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

• Understand the requirements of ISO 13485:2016 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

WHAT ARE THE MEDICAL DEVICE MANAGEMENT SYSTEMS COURSES AVAILABLE?

Available Medical Device Management Systems instructor-led courses include:

• ISO 13485:2016 Medical Device Management Systems Awareness
• ISO 13485:2016 Medical Device Management Systems Internal Auditor 
• Medical Device Single Audit Program (MDSAP) Awareness 
• Biocompatibility and Toxicological Risk Assessment of Medical Devices – The Notified Body Perspective Training
• In Vitro Diagnostic Regulation Training

WHAT IS THE COURSE METHODOLOGY?

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

  • WHO SHOULD TAKE THE MEDICAL DEVICE MANAGEMENT SYSTEMS COURSES?

    The courses are specially designed 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, Regulatory Affairs personnel
    • Consultants in the medical device industry
  • 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 THE MEDICAL DEVICE MANAGEMENT SYSTEMS COURSES?
    • 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, simply select the course which you would like to register for, click 'Register’ and fill out the forms 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 enrolment?
      Yes, please contact us at [email protected] for more details. Terms and conditions apply. 
    5. Can I also attend the E-learning module 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 [email protected]  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.

    To know more about TÜV SÜD, please click here.

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