Tissues and Complex Materials: Why Toxicology-Chemistry Collaboration Matters

With increasing emphasis from regulatory agencies on chemical characterization of medical devices under ISO 10993-18, it is important to ensure that a risk-based strategic approach is jointly developed by an experienced toxicologist and analytical laboratory. A proper study design should balance regulatory requirements, toxicological objectives, and practical laboratory considerations. For complex device materials—such as human- or animal-derived tissues, hydrogels, silicone implants, absorbables, and similar materials—the study design may present unique challenges. Devices composed of complex materials often require a highly individualized and nuanced study design. Regulatory success can be greatly improved when these programs are both developed and executed through close collaboration between the toxicologist and the extractables laboratory.

During this webinar, we will discuss:

• Toxicological considerations for the chemical characterization of tissues and other complex materials
• Principles of study design and risk-based approaches for challenging chemical characterizations
• Examples of individualized study plans for a variety of complex materials, developed in collaboration with a toxicologist and successfully applied in regulatory submissions

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