Fundamentals of Medical Device Single Audit Programme (MDSAP)
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 recognized auditing organization, to satisfy the needs of multiple regulatory jurisdictions.
Through our online MDSAP training, you will get an overview of MDSAP, including the objectives and requirements of the audit program, and the impacts of the model to your organization.
- 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
This course is specially designed for:
- Quality Assurance and Regulatory Affairs professionals
- Internal auditors, Quality engineers, Manufacturing engineers within medical device industry.
Our online MDSAP personnel certification course offers a wide range of benefits for professionals seeking to enhance their knowledge and expertise.
- 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.
- Professional Certification
Get a globally recognised certificate and enhance your career development.
System requirements
- Chrome
- Safari
- Internet Explorer
- Firefox
- 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.
1. 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.
2. 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).
3. 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.
4. 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.
5. 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.
The online MDSAP fundamentals training course employs a variety of tools such-as content-embedded assessment, and other interactive exercises to enhance the learning experience. Easily accessible via your preferred choice of device, the course allows you to log in and learn whenever, wherever.