Optimizing the Biological Evaluation Plan
The requirements for assessing the biological safety of products have increased significantly in recent years. The 2025 update to ISO 10993-1 plays a particularly important role in this context.
In this interactive workshop, you will work together on a fictional product example. Together, you will determine which parameters should be included in the biological evaluation plan, what requirements apply to a test sample or reference product, which data is relevant for the safety assessment, how the choice of materials can influence the test strategy, and how to develop a product-specific test strategy.
Optimize your test plan development and learn how to structure your test strategy effectively.
This workshop is intended for professionals who already have practical experience in the field of biocompatibility.
- Content
- Planning the Biosafety Assessment
- Required elements for the study plan
- Relevant data for preparing the study plan
- Your Benefits
- You will learn how to successfully plan and implement a biological safety assessment.
- You will identify the data required to plan a biological safety assessment.
- You will learn about the requirements for reference products.
- You will be able to develop a biological safety assessment plan.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Medical device manufacturers
- Technical documentation authors
- Regulatory affairs managers
- Research and development
- Quality management
- Research and development staff
- Service providers
- Suppliers
