This interactive webinar was developed to help you understand the latest elements of the latest version of the new ISO (14155), the International Good Clinical Practice standard for clinical investigations with medical devices. You will learn which and how additions impact the operations of your clinical investigations with medical devices.
The European Regulation 745/2017 on medical devices impose that clinical investigations comply with Good Clinical Practice as outlined in the ISO 14155 standard. Recently the 3rd version of this international GCP-standard has been released. This 1,5-hour highly interactive webinar is intended to provide you with the additions compared to the previous version. Also, the impact of the changes in clinical investigations will be presented, by delving into elements such as risk-based quality management, remote monitoring activities, monitoring plan, requirements at different development stages.
Be prepared to share any specific questions you may have and benefit from the knowledge of the facilitator as well as the other attendees.
Session: from 10am to 11h30am
Click here for the full ISO 14155 training