Interdisciplinary skills for Medical Device Experts
The interplay between biocompatibility and risk management is crucial to the safety and effectiveness of medical devices.
With the new ISO 10993-1, the importance of biological risk management has grown significantly. It is no longer viewed as a “secondary task,” but rather as a central component of the overall biocompatibility assessment. For you, this means that risk management must be more thorough, comprehensive, and structured than in previous versions.
Specialists from both fields must work closely together to ensure that the materials and design of medical devices meet the highest safety standards while minimizing risks. This seminar provides you with the tools and knowledge to make the most of this critical interface.
The seminar is aimed at both professionals involved in the biological assessment of medical devices and risk management experts. The goal is to develop a deep understanding of the interactions between biological safety and risk management and to learn practical strategies for integrating both disciplines into the product development process.
- Content
- Interface Analysis: Biological Evaluation and Risk Management According to ISO 10993-1 and ISO 14971
- Material and Chemical Characterization as Part of Hazard Identification: Requirements and Best Practices
- Optimization of Testing Strategies Considering Biological and Toxicological Risks to Support Risk Assessment
- Biological safety through appropriate risk controls: Inputs for development and production
- Life cycle analysis and its significance for risk assessment
- Particle toxicity
- Successful documentation and communication of results from biological evaluation and risk management
- Your Benefits
- You will gain in-depth knowledge of the requirements for biocompatibility and risk management in accordance with the MDR and relevant ISO standards.
- You will learn how to integrate biological risks into the entire product lifecycle and manage them effectively.
- You will discover how interdisciplinary collaboration can help you enhance the safety of your medical devices.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Professionals in biocompatibility testing
- Risk management experts
- Medical device manufacturers
- Regulatory affairs managers
- Developers and engineers in the medical technology sector
