Description: The ISO 20916:2019 standard on Good Study Practice for in vitro diagnostic medical device (IVD) studies represents an essential tool for conducting clinical performance studies in compliance with the European In Vitro Diagnostic Regulation (IVDR) requirements. The session will provide real life examples of how ISO 20916 requirements compare with methods used to manage a large international IVD study conducted in Europe and the US. This session will consist of two 30-minute presentations and will include time for questions.
The 1st presentation of the session will describe the study planning phase including quality system set up and preparation of study documents.
The 2nd presentation of the session will focus on compliance with the ISO 20916 standard during the data collection phase of the study providing details on the control mechanisms adopted to ensure data quality.
During both parts of the session, useful tips on study conduct to avoid problems and delays will be provided. This approach will help IVD manufacturers to better understand how to transfer theory to compliant and effective study practice.
Upon completion, participants will be able to describe best practices for developing key study documents and selecting a suitable data collection system for meeting requirements of ISO 20916:2019
Upon completion, participants will be able to describe useful control methods which can be adopted during the study to ensure data quality and acceptance by Notified Bodies and Regulatory Authorities
Upon completion, participants will understand the types of changes in IVD manufacturer organisations and quality systems that will be needed to implement conformity with ISO 20916:2019 practices