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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Focus on Fundamentals: Day 2 – Considerations for Biocompatibility

Published Date: August 29, 2024

Biocompatibility assessments involve extensive evaluation, and changing the sterilization modality, such as to VH2O2, can trigger considerable, new resource-intensive testing. The session will highlight collaborative efforts between the FDA and industry to develop a tool to streamline evaluations. At present, however there are still ways to streamline the impact of switching to VH2O2. We will discuss what should be considered in order to investigate the impact of VH2O2 on the overall biocompatibility profile of a medical device.

Attend this webinar and learn:

  • Regulatory considerations for change to VH2O2
  • How sterilizing agents can impact materials
  • What to consider for evaluation of impact to biocompatibility
Helin Räägel, PhD

Helin Räägel, PhD

Biocompatibility Expert

Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience. She works closely with...

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