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Toxicological Risk Assessment for Medical Devices: An Important Tool for Designing a Biocompatibility Testing Plan

October 17, 2019 @ 11:00 am - 12:00 pm

Toxicological Risk Assessment (TRA), which is based on E&L studies or material composition, is an important tool for assessing the safety of medical devices and designing biocompatibility testing plans. TRA’s can provide adequate evidence for circumventing unnecessary animal testing in the safety evaluation of medical devices.

Under 10993-1: 2018, FDA has solidified the role of toxicological risk assessment of medical devices, and it is showing an increasing demand for toxicological risk assessment in conjunction with chemical characterization (E&L studies). The participants will learn about:

  • Toxicological Risk Assessment: Paradigm and Processes
  • The implication of new guideline ISO 21726:2019 for the risk assessment
  • Importance of E&L studies in risk assessment
  • Pros and Cons of material composition-based risk assessment
  • Case studies of risk assessment

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October 17, 2019
11:00 am - 12:00 pm
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