This workshop presents the latest changes to the ISO 10993 standard series for the biological evaluation of medical devices. These changes might have significant implications for the biological safety assessment of all medical devices. The focus will be on the essential adjustments required to address these new challenges. Participants will learn how to implement these changes, identify gaps in the available data set, and apply the relevant testing and evaluation methods. The workshop will also cover the practical application of ISO 14971 principles for risk analysis and management, providing professionals with the knowledge needed to ensure the safety of medical devices and efficiently apply the standards in practice.
Workshop Language: English
For any information you can contact us at: medical-device@bpt.eurofinseu.com