Aml Research

Changes in ISO 14155: 2020 GCP for medical devices

Major topics of the training:

The ISO 14155 standard provides crucial guidance and support to any party involved in a clinical investigation. The third revision ISO151455:2020 brings significant changes and improvements in the conduct of clinical research with medical devices. This course will provide a description of the major changes to the second version ISO14155:2011 and also a comprehensive and practical guidance on how to implement the new requirements.


  • Background
  • Position of ISO14155 in the regulatory field
  • Overview of major differences with previous edition
  • Review
  • implementation in ongoing and future clinical investigations

Who should take the course?

Prior training in the second revision ISO14155:2011 is prerequisite . The course is therefore relevant to any research professional active in clinical investigations:


Duration: 170 minutes

Price: 215 € (Excluding VAT chargeable in Belgium and EU)

Course dates (Live webinar):

Tuesday  September 14, 2021 at 20:00 CET

Monday October 04, 2021 at 13:30 CET

Other dates will be published shortly

Booking on to a course: 

If you want to register for this course, please send an email to and mention:

Course title
Course date
Title, First Name, Last Name and email addresses of trainees
Invoice details

Requests for registration should be send at least 3 days (72 hours) prior to the course date.

We will then provide you via email with a confirmation of registration and further information.

AML has the right to cancell the course if there are not more then 3 participants registered.