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ISO 14971:2019 Awareness Training

Awareness Program on Risk Management

about the ISO 14971:2019 course

Implementation of Risk Management is a one of the primary requirements while demonstrating the compliance to regulatory requirements and conformance to Quality Management system requirements to ISO 13485 Standard for Medical Device and In-vitro Diagnostic device manufacturers.

While analyzing the reasons for the product failures, most of the time it leads to inadequacy in understanding and implementation of risk management in the organization. This training is to create awareness of requirements and to have better understanding.

Duration: 2 Days
Language: English

what will you learn from the course?

Upon completion, participants will be able:

  • To have better planning and framework of risk management
  • To demonstrate compliance to regulations
  • To have structured approach while implementation
  • To learn the overview of risk management activities
  • To ensure product development with desired quality and safety standards
  • Integration of risk management into an existing Quality Management System 

Topics to be covered in the course include:

  • Introduction to ISO 14971:2019 
  • Links to regulatory requirements 
  • Understanding pf ISO 14971:2019 standard and implementation 
  • General requirements for risk management system 
  • Risk analysis 
  • Risk evaluation 
  • Evaluation of overall residual risk 
  • Risk management review 
  • Production and post-production activities 
  • Application of risk management in QMS 
  • Exercise 

WHAT IS THE COURSE METHODOLOGY?

There is a balance between knowledge-based presentation, discussions, exercises and case studies.

Exam details:

Participants will be assessed through a 50 marks written examination (open book) at the end of the course. Minimum passing % criteria: 70%.

Certification details:

Participants who score 70% and above in the written examination will be issued a TÜV SÜD South Asia’s course completion certificate. Unsuccessful candidates will be issued a certificate of attendance.

WHO SHOULD take the course?

  • Product Risk Managers
  • Quality Assurance
  • Regulatory Affairs
  • Research & Development
  • Project Managers
  • Operations Managers
  • Manufacturing Managers
  • Engineers

Prerequisites: None

  • 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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