Aml Research

ISO14155: 2020 GCP for medical devices

Topic of the training:

The recently issued third revision ISO151455:2020 brings significant changes and improvements in the conduct of clinical research with medical devices. It outlines standards for the design, conduct, recording and reporting of clinical investigations with medical devices and provides manufacturers with information on how to implement GCP for pre- and post-market clinical investigations to determine safety and performance of a medical device. This course will provide a description of the content of the standard and also includes a guidance on how to implement the requirements in your day-to-day work.

Content:

  • Background
  • Position of ISO14155:2020 in the regulatory field
  • Scope
  • Ethical considerations
  • Informed Consent
  • Clinical investigation planning, conduct and close-out
  • Responsibilities of sponsor
  • Responsibilities of principal investigator

Who should take the course?

It is aimed at any research professional active in clinical investigations

 

Duration: 240 minutes


Price: 360 € (Excluding VAT chargeable in Belgium and EU)


Course dates (Live webinar):

  • Monday March 22, 2021 at 09:00 CET
  • Tuesday April 13, 2021 at 13:00 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 training@aml-research.be 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.