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Fundamentals of Medical Device Single Audit Programme (MDSAP) E-learning Course

Achieve access to multiple markets with a single audit

ABOUT THE COURSE

To improve the safety and oversight of medical device manufacturing on a global scale, the Medical Device Single Audit Program (MDSAP) is developed to allow for a single regulatory audit of a Medical Device manufacturer by a MDSAP recognised auditing organisation, to satisfy the needs of multiple regulatory jurisdictions.

Introducing Medical Device Single Audit Program (MDSAP) Awareness course.

Through this course, you will get an overview of MDSAP, including the objectives and requirements of the audit program, and the impacts of the model to your organisation. You will also learn about benefits of MDSAP such as the reduced time to gaining access to multiple markets with a single audit program that satisfies the needs of multiple regulatory authorities.

This e-learning course is especially designed for learners on the go. It provides you the convenience of self-paced learning allowing you to boost your competency and add value to your career.

WHAT WILL YOU LEARN FROM THE COURSE?

In this course, you will discover the fundamentals of MDSAP and gain an understanding of MDSAP Audit structure and core processes. In addition, you will discover how to apply and align MDSAP to the internal audit programme.

Topics to be covered in this course include:

• Overview and Objectives of MDSAP
• Benefits of MDSAP
• Roles and Responsibilities
• Uses of MDSAP
• Process Structure and Audit Tasks
• Nonconformity Grading System
• Impact of Audit Model to Organization 
• Documentation and Reporting

WHAT IS THE COURSE METHODOLOGY?

The course employs a variety of training tools such as content-embedded assessment, simulations, and other interactive exercises to enhance instructional delivery. Easily accessible via your preferred choice of device, the course allows you to log in and learn whenever, wherever.

The cumulative duration of the programme is 105 minutes, after which you will be required to pass a quiz to receive your internationally recognised e-certificate with a unique ID.

WHO SHOULD TAKE THE COURSE?

This course is specially designed for:

• Quality Assurance and Regulatory Affairs professionals
• Internal auditors, Quality engineers, Manufacturing engineers within medical device industry

Prerequisite: None 

WHO IS THE COURSE ADVISOR?

Designing the course content and structure are domain experts from TÜV SÜD’s Digital Academy Approval Board.

Based in various locations worldwide, these are specialised trainers who have been working with top-notch employers and industry associations to achieve business excellence with the Medical Device Single Audit Program (MDSAP). The global reach of our experts ensures that you get access to relevant learning modules and best practices in MDSAP. 

  • WHAT ARE THE BENEFITS OF ENROLLING IN THIS COURSE?
    • World-Class Training
      Learn from TÜV SÜD’s industry experts and training specialists
    • Flexible Learning Style
      Study in your own time, at your own pace
    • Continuous Feedback
      Get prompt feedback from content-embedded assessment
    • Competency-Based Learning
      Show your course progress based on demonstrated learning
    • Professional Certification
      Get a globally recognised certificate and enhance your career development
  • FAQs
    1. How do I enroll for the course?
      To enroll, simply select the course which you would like to register for, fill out the form on the webpage accordingly.
    2. What is included with the course?
      You get access to our e-learning content along with the assessments that will help you understand the topics in depth. In the event of any technical difficulties, you can contact us for support.
    3. Can I pause the course and log in to it anytime?
      Yes. The course allows you to take a break and return to it within the defined access period.
    4. Are there any tests in the middle of the course?
      Yes, there are interactive quizzes throughout the course to gauge your understanding of the lectures.
    5. Can I get a refund if I cancel my enrolment?
      No, refund is not possible once the account is activated.
    6. What happens if I don't finish the course within the access period?
      Access period may be adjusted for B2B customers depending on what was agreed in the contract. For B2C customers, access runs only for 30 days.
    7. I have difficulty accessing the course. Whom should I contact?
      To contact someone from TÜV SÜD, you may email us at [email protected] or call +1800-212-2000.
    8. Who developed the course and what are their qualifications?
      The course is developed by TÜV SÜD’s Digital Academy Approval Board. The experts undergo relevant upskilling programmes, benefitting from TÜV SÜD’s 150 years of expertise and global heritage.
    9. Whom do I contact if I want more in-depth course materials?
      To contact someone from TÜV SÜD, you may email us at [email protected] or call +1800-212-2000.

    To know more about TÜV SÜD, please click here.

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