Reproductive and Developmental Toxicity Studies Services

Reproductive and developmental toxicity studies are conducted to evaluate the potential adverse effects of medical device materials or their chemical extracts on reproductive health and offspring development. These studies assess the impact on fertility, reproductive capability, embryonic and fetal development, as well as the growth and health of offspring.

Such evaluations are essential for medical devices that may come into prolonged or repeated contact with the body, particularly those used during pregnancy or in reproductive health applications. The testing typically involves in vivo studies that monitor key reproductive parameters and developmental milestones across one or more generations.

The data generated from these studies help determine whether a device poses any risk to reproductive function or developmental processes. This information is critical for regulatory approval and for ensuring patient safety, especially for populations that may be more vulnerable, such as pregnant women and children.