Basic Biocompatibility: Practical Perspective and Regulatory Aspects

Duration: 2 x 3 hours
Date: 8.04. & 10.04.2025
Speaker: Monica Grekula; Lina Burman

Training objectives:

By developing a basic understanding of biocompatibility-related issues and requirements you can reduce the likelihood of:
• Time-consuming and costly mistakes when choosing materials;
• Having to re-do testing;
• Biocompatibility-related adverse events following material changes;
• Deviations related to material changes at audits; and
• Questions at filing to notified body and authorities.

The course will improve your understanding of biocompatibility to:
• Ensure timely consideration of biocompatibility-related aspects during development;
• Facilitate discussions with those responsible for biological evaluation and test houses; and
• Ease reviewing of biocompatibility-related documentation for regulatory purposes or clinical evaluations.

The course also gives a good introduction to the area if you’ll be working with biological evaluations and you’re new to the field.

Training content:

• Definition and connection to other processes - risk management, clinical evaluation, quality system process (ISO 14971, ISO 14155, ISO 13485) and Design Development
• ISO 10993-1 general principles and process
• Endpoints of concern and product-specific hazards
• Information needed for biological evaluation, incl. choice of chemical information or chemical analysis
• Overview ISO 10993 remaining standards
• Changes that trigger update of evaluation and case studies
• Basics to think about in material selection and dealing with suppliers
• Basics to think of when setting up tests with test house
o Biological testing
o Chemical characterization
• Key points to be covered due to the EU MDR 2017/745 GSPR
• What notified bodies want to see
• Global aspects
• Group exercise


Training format:

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

Price: 625EUR