Update Seminar on the Revision of ISO 10993-1
ISO 10993-1 is at the heart of the biological evaluation of medical devices—and its update brings significant changes for manufacturers, developers, and regulatory professionals.
In this concise update seminar, you’ll receive a targeted overview of all relevant changes to ISO 10993-1. Learn which specific requirements have changed, how to interpret them from a regulatory perspective, and how to adapt your existing biocompatibility assessment to ensure it’s future-proof.
- Content
- Overview of the Changes to ISO 10993-1
- New Requirements for Biological Risk Analysis
- Updated Requirementsfor Chemical Characterization and Toxicology
- New Structure for Product Categories and Endpoints
- Impact on MDR Documentation and Technical Documentation
- Your Benefits
- Quality and regulatory affairs professionals in the medical device industry
- Quality and regulatory affairs professionals in the medical device industry
- Professionals responsible for biological evaluation and toxicology
- Developers and project managers involved in material selection
- Specialists who wish to adapt their processes to the latest state of the art
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Quality and regulatory affairs professionals in the medical device industry
- Quality and regulatory affairs professionals in the medical device industry
- Professionals responsible for biological evaluation and toxicology
- Developers and project managers involved in materialselection
- Specialists who wish to adapt their processes to the lateststate of the art
