In Vitro Diagnostic Regulation (IVDR) - Medical Devices E-learning
This is a foundation level course on In Vitro Diagnostic Medical Devices Regulation (IVDR). It covers basic information about the new regulation, classification of rules and procedure to carry out the assessment. The course is divided into three modules that details on Technical Documentation requirements under IVDR. Quality Management System requirements under IVDR and Understanding of traceability requirements and post-market surveillance under IVDR.
The Technical Documentation requirements under the IVDR module are created for building an understanding of regulations and technical documentation that play an important role in IVDR. Further the requirements of Quality Management System which emphasize on Article 10 (8) of EU MDR 2017/746, under the general obligation of manufacturers states that manufacturers must demonstrate performance, safety and possible risks/controls of products prior to availability within the European marketplace.
This E-learning course is specially designed for manufacturers of medical devices, Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance Personnel, Students and Professors.
- Learners will learn to explain the In Vitro Diagnostic Medical Devices Regulation.
- Learners will gain awareness of the new IVDR on quality management system and requirements according to Article 10 (8).
- Learners will be able to define key terms with regard to IVDR.
- Technical Documentation requirements.
- Quality Management System requirements.
- Understanding of traceability requirements and post-market surveillance under IVDR.
This E-learning course offers an accelerated learning through its bite-sized modular structure. The flexibility of this self-paced E-learning means it is accessible on any device 24/7. You have the opportunity to start, pause, replay, and even restart the course at your own convenience. Upon completion of this E-learning course, you will receive a globally recognised TÜV SÜD certificate.
Upon completion, you will receive your globally recognised TÜV SÜD certificate on In Vitro Diagnostic Medical Devices Regulation (IVDR).
TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Academy UK offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Academy do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us.
System requirements
Supported browsers include:
- Chrome
- Safari
- Internet Explorer
- 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 the 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 before 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, contact us here.
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