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Biological Evaluations for European Union Medical Device Regulation: Challenges, Experiences, and Tips

Date and Time:Thursday, May 16, 2024 at 11:00 AM to 12:00 Noon (US EDT, UTC -5)

Hosted by: The SOT Medical Device and Combination Product Specialty Section

Registration is required for this free webinar.

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Adapting the biological evaluation to the market you want to put your product in is sometimes called regulatory toxicology. While there are usually underlying reasons for the approval requirements, they are sometimes difficult to interpret. The ultimate goal is to have safe products while also gaining quick market access. This webinar offers perspectives from speakers based in Europe who have extensive experience in working with different Notified Bodies (NB) and products of different risk classes. They also plan to highlight how the requirements differ from the US FDA. They will share challenges and experiences gathered during their time as consultants in the field.

Speakers:

  • Lina Burman, PhD, Sr. Scientific Affairs Manager, Biocompatibility and Toxicology, Veranex
  • Monica Grekula, ERT, MSc, MSc, Sr. Director Scientific Affairs, Biocompatibility and Toxicology, Veranex

Registration is required for this free webinar.

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