Basic Biocompatibility: Practical Perspective and Regulatory Aspects

Duration: 2 x 3 hours
Date: 6.11. and 11.11.2025
Duration: 6 hours | 2x 2:00 – 5:00 PM CET, 2 x 8:00 – 11:00 AM EST
Speaker: Monica Grekula and Lina Burman

Training objectives:
By attending this training, you will gain a foundational understanding of biocompatibility requirements and related challenges. This knowledge will help you minimize the risk of:
- Costly and time-consuming errors in material selection
- Repeating biocompatibility testing
- Adverse events related to material changes
- Audit deviations linked to material modifications
- Regulatory questions from Notified Bodies and Authorities during submissions

This course will enhance your understanding of biocompatibility to help you:
- Ensure timely integration of biocompatibility considerations during product development
- Communicate effectively with biological evaluation teams and testing laboratories
- Confidently review biocompatibility documentation for regulatory submissions and clinical evaluations

The course also serves as an introduction for those new to the field of biological evaluation. Key considerations from ISO/FDIS 10993-1:2025 will be covered, providing essential context for current and emerging biocompatibility requirements.

Training content:
- Introduction to biocompatibility: definitions and links to other processes
- Overview of the ISO 10993 series
- ISO 10993-1: General principles and risk-based approach (current and FDIS 2025 version)
- Identifying biological hazards and relevant biological endpoints
- Information requirements for biological evaluations
- Basic considerations for material selection and supplier management
- Essentials for planning and coordinating with test laboratories
- Triggers for updating biological evaluations
- Key biocompatibility aspects under EU MDR 2017/745 and GSPRs
- What Notified Bodies expect in submissions
- Global regulatory perspectives
- Practical exercises and case studies

Training format:
• Presentations with interactive discussions
• Group and individual exercises
• End of training assessment

Who should attend:
This course is designed for beginners and those with basic biocompatibility needs. It is ideal for professionals who require a foundational understanding of biocompatibility, including:
Project managers and engineers
Regulatory affairs managers
Quality engineers
Sustaining engineers
Professionals involved in vigilance investigations or clinical evaluations
Individuals new to biological evaluations


Price:
EUR 625 incl course material and certificate .