Successfully Implementing Biocompatibility Testing According to ISO 10993
The goal of all medical device manufacturers is to provide patients with maximum benefit while minimizing biological risks.
The importance of biocompatibility has increased enormously in recent years. 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 of biological risk assessment.
Learn how you canoptimizethe testing strategy for the biological safety testing of your medical device(s), which current standards you must follow, and how to successfully conduct biocompatibility tests.
The current approach to toxicological risk assessment according to ISO 10993-17:2023 is also taken into account.
- Content
- Fundamentals and Definitions
- Overview of Relevant Standards for Biological Evaluation
- Biological Evaluation According to ISO 10993-1
- Material characterization and chemical characterization
- Analysis of the materials used and the manufacturing process
- Chemical analysis of leachable substances
- Toxicological risk assessment
- Biological testing
- Consideration of the life cycle of a medical device
- Special case: Particle toxicity
- Documentation
- Your Benefits
- Learn about the various biological safety requirements under Regulation (EU) 2017/745 and ISO 10993.
- You will learn how to plan and conduct risk-based biological testing and evaluation of your medical devices.
- Discover how to effectively and efficiently implement these requirements within your organization and adapt them to your product portfolio.
- You will be able to integrate the biological assessment process into your existing development process as well as into your risk management.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, tried-and-true exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Medicaldevice manufacturers
- Technicaldocumentation writers
- Regulatory affairs professionals
- Qualitymanagement professionals
- Research anddevelopment staff
- Serviceproviders
- Suppliers
