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INTRODUCING MEDICAL DEVICE REGULATION TRAINING

Understand the requirements of Medical Device Regulation (MDR)

ABOUT THE COURSE

The European Union’s Medical Devices Regulation (MDR 2017/745/EU) was officially published on 5 May 2017 and came into force on 25 May 2017. It will eventually replace the Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMD 90/385/EEC). Manufacturers of currently approved medical devices under MDD and AIMD will have a transition time of three years until 26 May 2020 to meet the requirements of the MDR. For certain devices, this transition can be extended until 26 May 2024.

The MDR introduces numerous changes, including shift from pre-approval stage to life-cycle approach. It also incorporates European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluation and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers.

Duration: 1 - day course

WHAT WILL YOU LEARN FROM THE COURSE?

Topics to be covered in this course include:

Introduction to MDR
Classification of medical devices
Conformity assessment procedure
Technical documentation requirement
General Safety and Performance Requirements
Clinical data & clinical evaluation requirements
Post-Market Surveillance, vigilance and market surveillance 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 suitable for Medical Device professionals that are in areas such as:

  • Quality & Risk Management, R&D, Manufacturing, etc.
  • Anyone who is working in the Medical Device sector that market products to the EU

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 [email protected] 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 [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.
    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 [email protected] .

    To know more about TÜV SÜD, please click here.

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