Toxicological assessments
Product & material safety
Toxicological assessment is a scientific analysis focused on identifying and evaluating the potential toxic effects of substances used in medical devices and drugs. This process involves studying the nature, severity, and duration of toxic effects under various exposure conditions. Toxicologists examine a range of factors, including dosage, exposure routes, and the compound’s interaction with biological systems.
Toxicological assessments
Cleaning validation
Cleaning validation in medical device and drug manufacturing is a critical and regulatory-mandated process to ensure that health care products are free from contaminants and residues that could be harmful to patients.
IASON consulting can assist with cleaning validation and prepare toxicological assessments as well as define thresholds for potential contaminants.
Toxicological thresholds
Toxicological thresholds are essential for ensuring that drugs are both safe and effective for patient use. Our toxicologists are happy to help.
Toxicology
PFAS in medical devices
PFAS are widely used in medical devices due to their functional properties. At the same time, increasing regulatory restrictions are expected, raising the need for dedicated toxicological assessments.
IASON consulting provides toxicological assessments of PFAS in medical devices, applying structured, scientifically robust methodologies to address significant data gaps and still derive defensible conclusions in line with MDR, ISO 10993, and REACH.
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