Solution-focused toxicological risk assessment and medical device biocompatibility consulting

Download center: Updates and training guidance on ISO standards for toxicological risk assessment, solvent polarity tables for E/L study design, author poster presentations, and a rogues gallery of examples of GC/MS peak misidentification.

Toxicological Risk Assessment Under ICH Q3E for Drug-Device Combination Products

Pending Updates to ISO 10993-1 (2025)

Discoveries on Applying the New ISO 10993-17: Approaches that Achieved Favorable Outcomes in Extractables Studies

Meeting New Challenges in Toxicological Risk Assessment: Changes to ISO 10993-17:2023

2024 Updates to ISO 18562, Biocompatibility evaluation of breathing gas pathways

SOT 2025 - Re-Examining the Key Characteristics of Cancer for Metallic Elements: Lines of Evidence to Support Mechanisms of Action Leading to a Threshold Model for Carcinogenic Response

SOT 2024 - Genotoxicity and Carcinogenicity Risks in Medical Devices - A Review of Case Studies Using Approaches from ISO 10993-17 and ISO 10993-3

SOT 2019 - E/L for a drug coated balloon catheter combination product

SOT 2018 - Ventricular catheter - exhaustive extractions

SOT 2017 - SVOC Breathing Circuit - Compare Analytical Data Sources

ISO 18562:2017 - Toxicological Risk Assessment for Breathing Gas Pathway

Solvent Polarity Table

Rogues Gallery of GCMS Peak Misidentifications