Latest Biocompatibility Insights: Managing Biocompatibility Across Regulatory Landscapes and Product Lifecycles

This workshop will cover the recent update of ISO 10993-1, which is crucial for the biological evaluation of medical devices. We will discuss the latest regulatory feedback and state-of-the-art strategies to ensure compliance with the applicable standards. Additionally, we will focus on the assessment of changes in medical devices, which involves conducting thorough risk analyses. Furthermore, we will also present some of the most frequent inquiries raised by regulatory agencies regarding biological safety, along with strategies for addressing unexpected results.

Staying updated with these practices is essential for maintaining high standards and adapting to new requirements and methodologies.

Workshop Language: English

For any information you can contact us at: medical-device@bpt.eurofinseu.com