Clinical Operations Courses
Part of a STAR Programme

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.

Course time
09h00 - 17h00
Who should attend

Project Managers, CRAs, study co-ordinators or Investigators working on Clinical Investigation with Medical Devices

Programme highlights
  • Focus on the overall content and structure of the ISO14155 standard
  • In depth review of responsibilities of each of the medical device stakeholders
  • Practical implementation of the standard
Learning Objectives
  • Understand the role of clinical studies in the development of devices
  • Be familiar with the basic requirements on how clinical trials are carried out
  • Appreciate the device-specific study elements as compared to drugs studies
  • Be familiar the participants with expected clinical tasks



This course covers competencies that are part of the ECCRT Competency Framework:

  • Scientific Concepts & Research Design (0)
  • Ethical & Participants Safety Considerations (4)
  • Investigational Product Development and Regulation (4)
  • Clinical Studies Operations (GCPs or ISO 14155) (7)
  • Study and Site Management (0)
  • Data Management and Informatics (4)
  • Leadership and Professionalism (1)
  • Communication (0)
  • Teamwork (0)
  • Business acumen (0)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained

Book a course

Date Lang Location
Proceeding your application may take up to 24 working hours. In case of question, contact

Booking is desired 1 week before F2F session in order to allow the participant to go through pre-read materials.
800,00 € excl. VAT (if applicable)


Jozef Tanczos
January 2019
Miracor Medical

I am thankful for Marleen and Benedikt that have provided a very enriching experience not only for me but to all participants, through an interactive course and case based training, striving people to participate rather than just listening, and through the participation of an audience with mixed level of experience. The feedback I received from them was positive, considering the experience they have in the field and business. They confirmed the training session provided implementable knowledge for their day-to-day work, especially through the case-based workshops.