An Introduction to Biocompatibility for Medical Devices
Medical device manufacturers focus on developing products that offer maximum benefit to patients while posing minimal biological risk.
For this reason, consideration of biocompatibility is of great importance. Regulations such as Regulation (EU) 2017/745 (MDR) require proof of biocompatibility for all materials that come into direct or indirect contact with patients. Biocompatibility testing is an integral part ofthe biologicalrisk assessment.
Get a basic overview of relevant standards (e.g., the current version of ISO 10993-1:2025), insight into relevant chemical and biological endpoints, and aspects of documentation.
- Content
- Fundamentals and Definitions
- Overview of relevant standards for Biological Evaluation
- Categorization of Medical Devices sased on clinical use
- Relevant chemical and biological endpoints
- Introduction to documentation
- Your Benefits
- Gain insight into the various aspects of biocompatibility.
- You will understand the fundamentals of biological and toxicological assessment.
- Learn how extractable substances can be characterized and classified.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Medical device manufacturers
- Employees and career changers who wish to familiarize themselves with biocompatibility
