Fundamentals of Medical Device Awareness Single Audit Program (MDSAP)

This course is specially designed for:

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

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 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

The Medical Device Single Audit Program (MDSAP) was developed in order to improve the safety and oversight of medical device manufacturing on a global scale. The program allows for a single regulatory audit of a Medical Device manufacturer by a MDSAP recognised auditing organisation, and satisfies the needs of multiple regulatory jurisdictions.

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 provides the basic knowledge to prepare for the Medical Device Single Audit Program (MDSAP) and 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.

• 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

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. Participants must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

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System requirements

Supported browsers include:

• Chrome
• Safari
• Firefox

Additional requirements include:

• A high-speed internet connection will provide best results.
• An email address is required to register for courses.
• Microsoft Media Player or equivalent is needed to play audio and video files.
• Flash Player is used for content and interactive learning. If necessary, download and install Flash Player to ensure proper operation of course content.

What is included with the course?

Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included, and this will vary by course.

Can I pause the course and log in to it anytime?

Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).

Are there any quizzes in the middle of the course?

Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.

Can I get a refund if I cancel my enrollment?

Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.

What happens if I don’t finish the course within the access period?

The standard access period is 365 days to allow sufficient time to complete your course.

If you have questions, or require assistance, you may reach us at [email protected]

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