In Vitro Diagnostic Regulation (IVDR) - Medical Devices E-learning Training Course

Online Training105 MinutesOnlineE-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 additionally offers the opportunity to deliver this training as a dedicated in-house course, delivered solely to your organisation to meet your needs and requirements. To receive a quote and find out more information, please contact us at [email protected].

Net Price (excl. VAT)
£ 199.00