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
Conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components
Predicts the impact of extraction conditions, sample geometry and material properties on extraction test efficiency
CHemical RISk calculators (CHRIS) – Color Additives (v2)