In Vitro Diagnostic Medical Devices Regulation (IVDR)
This is a foundation level course on In Vitro Diagnostic Medical Devices Regulation (IVDR). It covers basic information about the new regulation and classification of rules and procedure to carry out the assessment. The online IVDR training is divided into three modules that address details of Technical Documentation requirements under IVDR. Quality Management System requirements under IVDR and Understanding of traceability requirements and post-market surveillance under IVDR.
**If you are unable play the video below, this could be because of your company IT policy may have restricted access to YouTube.
- Provide basic awareness of the new regulation
- Explain In Vitro Diagnostic Medical Devices Regulation
- Discuss the impact of the new IDVR on the quality management system and requirements under Article10(8)
- Describe some of the important terms such as market surveillance, unique device identification and their traceability.
This course is specially designed for:
- Manufacturers of medical devices
- Regulatory Affairs
- Design and Development
- Quality Management
- Quality Assurance personnel, clinical affairs specialists, students and professors
Our online IVDR 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 IVDR course employs a variety of training 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.