You are a monitor, a project manager or part of an investigator team and need to understand the counterpart of ICH-GCP for medical device trials. You want to know the rules and responsibilities outlined in ISO14155 and get some practical advice and tips on improving your medical device monitoring skills? This course is made for you and your colleagues!
This 1-day course brings CRAs and Investigators up to speed with the ISO14155, when working with device clinical trials. This standard is mandatory in Pre-Marketing studies but is very frequently followed in the Post-Market release study environment, especially when the results of these trials are to be published in major medical journals.
Although up to a certain level comparable to ICH-GCP, the ISO14155 standard features a series of requirements and terminologies that are very specific to medical devices. This course will guide the trainees through all the sections of this document.
A quiz, covering the most important items will end the training day, offering the trainees a brief rehearsal on what has been discussed during the training.