Toxicological Risk Assessment

The first step in biological evaluation is the gathering of physical and chemical information on the medical device or component.

We help you in creating Toxicological Risk Assessment based on:

• • • Chemicals used in materials of construction of a medical device
    • From impurities, processing agents, additives, contaminants, residues present on the device
    • Chemical characterization study (extractable/leachable) performed on a medical device
    • Reviewing published or available toxicological or biological data on relevant component materials
    • Information from biological tests
    • Information available on history of clinical use or human exposure