Impact of the EU MDR on the Risk Management Process for Drug-Device Combination Products

3/21/2022 09:40 - 10:10

  • Regulatory landscape changes
  • EU MDR requirements on device risk management process
  • Impact of the EU MDR on drug-device risk management process
  • Usability engineering/Human Factors (HF)
  • Benefit -risk assessment of drug-device combination product

Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices, Combination products and eHealth, Bayer