Medical Device Regulation – Technical Documentation E-learning
The European Medical Device Regulation (EU) 2017/745 (MDR) requires medical device manufacturers to provide a Technical Documentation for their devices. The Technical Documentation is a compilation of all relevant information on a product. It must be kept up to date throughout the entire defined product life cycle. Familiarize yourself with the basic requirements.
This training is intended for newcomers, engineers and consultants in the medical device industry as well as experts and executive personnel seeking to update their knowledge and for personnel in charge of regulatory affairs and quality management.
- Identify the requirements for Technical Documentation according to the MDR.
- Summarise the requirements of the presentation of Technical Documentation according to the MDR.
- Summarise the elements that Technical Documentation shall contain and identify any missing elements.
- Find out who shall have Technical Documentation available and in what state/status.
- Product verification and validation
- Technical documentation guidance for manufacturers
- Notified body involvement in technical documentation assessment
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 Medical Device Regulation – Technical Documentation.
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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