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StartseiteE-LearningsMedizintechnikEuropean Union Medical Device Regulation 745 (E-Learning)

European Union Medical Device Regulation 745 (E-Learning)

Produktnummer 08-064-24
  • E-Learning (Selbststudium)
  • E-Learning
  • Online
Details

•Understand the basic requirements of EUMDR 745 for Medical Devices other than IVDs

•Discover about the European Parliament and the Council on medical devices•List the regulations for medical devices exercised by the European Parliament under EUMDR •Define the different chapters and articles covered in EUMDR 745

Inhalte | Content

•Introduction and Need of EU Under MDR-745

•The European Parliament and The Council on Medical Devices•Inputs for Medical Devices with Nanomaterials•Responsibility of Distributors and Manufacturers•Chapters, Articles, and Annexures•EUDAMED: Introduction, Purpose, Elements•Key Roles of Notified Bodies & Classification of Devices•Clinical Evaluation and Investigations•PMS System, Periodic Safety Update Report (PSUR)•Market Surveillance, MDCG

Zielgruppe | Target group

This course is designed for employees of a medical device manufacturer, specifically for those working in quality assurance or regulatory affairs, and service providers to the industry.

Hinweis | Note

System requirements

Supported browsers include:

  • Chrome
  • Safari
  • Internet Explorer
  • Firefox

Additional requires 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 270 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 270 days to allow sufficient time to complete your course.

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

To learn more about TÜV SÜD, please click here.

100,00 €Nettopreis
120,00 €Bruttopreis
Preisdetails einblenden
Nettopreis100,00 €
20% USt.*20,00 €
Bruttopreis120,00 €
*Kann außerhalb von Österreich abweichen
In den Warenkorb

Wie können wir helfen?

+43 5 0528 3030

[email protected]

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