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Medical Device Regulation – Technical Documentation E-learning Training Course

Online Training70 MinutesOnlineE-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 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)
£ 180.00