Fundamentals Of Medical Device Single Audit Programme (MDSAP)

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.

In 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 MDSAP e-learning course is specially 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.

• 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 Organisation
• Documentation and Reporting

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

The course structure and content are developed by 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.

1. How do I enroll for the Fundamental of Medical Device Single Audit Programme (MDSAP) e-learning course?
To enroll, please click on "Buy now" and check out your cart.

2. What is included with the Fundamental of Medical Device Single Audit Programme (MDSAP) e-learning 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 Fundamental of Medical Device Single Audit Programme (MDSAP) e-learning course and log in to it anytime?
Yes. The Fundamental of Medical Device Single Audit Programme (MDSAP) e-learning 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 Fundamental of Medical Device Single Audit Programme (MDSAP) e-learning course?
Yes, there are interactive quizzes throughout the Fundamental of Medical Device Single Audit Programme (MDSAP) e-learning course to gauge your understanding of the lectures.

5. Can I get a refund if I cancel my enrollment?
No, refund is not possible once the account is activated.

6. What happens if I don't finish the Fundamental of Medical Device Single Audit Programme (MDSAP) e-learning 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. What is the methodology of the e-learning course?

• 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.