At VIMTA, our risk assessment testing for medical devices identifies and evaluates the toxicity of individual chemical constituent and predicts possible human exposure risks. Our risk assessment profile includes:
- In-silico risk assessment using Derek and Sarah Nexus Software
The latest ICH M7 guidelines necessitate that the computational toxicology assessment should be performed using two complementary (Q)SAR methodologies that predict the outcome of a bacterial mutagenicity assay, out of which one should be statistical based. The in-silico toxicity testing using Sarah Nexus is the quick, accurate and inexpensive way to identify potentially toxic chemicals, and is in accordance with the regulatory requirements.
- Toxicological Risk Assessment
The toxicological risk assessment of a medical device gathers all possible toxicity data and helps in determining whether a chemical compound present or released from a medical device poses a systemic toxic, genotoxic, carcinogenic, reproductive or developmental toxicological risk. As per ISO guidelines, for devices where the patient-contacting portions may contain potentially toxic chemicals, the evaluation of safety should include both chemical risk and the type and duration of exposure.