Medical Pre-Clinical Biological Safety

About this webinar

Medical device pre-clinical biological safety evaluation and related testing is key to moving technology from bench to patient. It supports early-stage clinical investigations, required regulatory approvals, and overall patient safety.

Psephos Biomedica are proud to present this expert-led webinar on this important topic. Join us to learn more about the key concepts, the appropriate methodology to use, practical insights for implementation and a Q&A session.

What will be covered

An introducation to ISO 10993 series principles from device developer perspective, including but not limited to the following topics:

• The available resources to prepare the biological safety evaluation strategy and the most appropriate testing plan.
• Introduction to ISO 10993-1: Evaluation and Testing within a Risk Management Process.
• Sample preparation process & considerations.
• The link between regulatory requirements and biological safety evaluation.
• How should study results be interpreted?
• Dealing with test failures and ambiguous results.
• What are the expected changes for the coming years?

Presented by

Christophe Naz is an expert in pre-clinical activities from the strategy preparation, through the study planning, follow-up, results interpretation until the technical file documentation, submission and eventual discussions with EU and US regulatory agencies. Christophe has led biocompatibility programs on Class II and Class III devices including bioresorbable technologies in multiple therapeutic areas such as Vascular, Cardiovascular, Peripheral Nervous System and Gastrointestinal. In addition, Christophe recently led and orchestrated the techincal file preparation of a Class III device until its US FDA IDE approval. Officially trained on ISO 109993 series and on animal experimentation.