TRAINING CENTRE

EU Medical Devices Regulation 745/2017

The following contents from Medical Device Regulation (MDR) are covered by the training in Slovenian language which includes practical samples:

  1. Scope and definitions
  2. Placing on the market and putting into service or use
  3. Usage of harmonized standards
  4. General obligations of manufacturers, importers and distributors
  5. Authorized representative
  6. Person responsible for regulatory compliance
  7. Single-use devices and their reprocessing
  8. EU declaration of conformity and CE marking of conformity
  9. Systems and procedure packs
  10. Unique device identification system
  11. UDI database
  12. Registration of devices
  13. Summary of safety and clinical performance
  14. Registration of manufacturers, authorized representatives and importers
  15. European database on medical devices
  16. Classification of devices and conformity assessment
  17. Clinical evaluation and clinical investigations
  18. Post-market surveillance, vigilance and market surveillance

 

Training does not include tasks and responsibilities of a notified body.

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Training Options

eLearning: which is given as self-paced web-based training. The content is available in Slovenian language. Training time depends on the basics that participant has in the field of good clinical practice, as the pace of content review depends on the individual. The training includes a test of knowledge. eLearning Centre User Manual.

Per client request we can arrange for a workshop with targeted training tailored to each manufacturer.

Issuing Certificates

Knowledge test consisting of 20 questions. To obtain a certificate, 16 questions (80 %) should be answered correctly.

For more information, please contact us at: info@adax.si.