ISO 14155 Training (GCP)

ISO 14155 is the harmonized standard that contains the requirements of good clinical practice for medical device trials. Our ISO14155 training contains practical examples and interactive assessments of turning this theoretical standard into practical use. Avoiding and recognizing common mistakes and understanding what full GCP implementation means. 


Our trainers have gained broad experience with ISO14155/GCP in practical settings as CRA, clinical trial manager, notified body reviewer etc. What are your responsibilities as a sponsor? How to implement good documentation practices? Is monitoring necessary and to which extend? Data handling in a practical and compliant way. All aspects of the standard will be discussed.

We can provide a training on location for your whole team, as well as at our office or in an online format.  


Our training is:

  •  Practical 
  • Given by experienced trainers
  • Interactive
  • ISO 14155 compliant
  • Considers the new MDR requirements
  • Places GCP in the broad framework of MD development and CE-marking

Our training is useful for manufacturers clinical staff, project/product managers, CRAs, investigators, on-site staff, RA managers, QA managers, etc. Whoever gets involved with clinical trials and clinical data in medical device development.




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