Regulatory Science Tools Catalog
This regulatory science tool is a method that applies the ISO 10993-17 toxicological risk assessment approach to medical device extractables screening data to assess systemic toxicity, genotoxicity, carcinogenicity, or reproductive/developmental toxicity in the biocompatibility evaluation of a medical device.
Chemicals List for Analytical Performance (CLAP)
A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method
Predicts the impact of extraction conditions, sample geometry and material properties on extraction test efficiency
CHemical RISk calculators (CHRIS) – Color Additives (v2)
Conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components