Devices Incorporating Tissues or Cells of Animal or Human Origin, or Their Derivatives: Data Expectations Under EU MDR
Diede van Bladel
24 Jun, 2025
Diede is a Regulatory Affairs Subject Matter Expert. She specializes in clinical trial applications and scientific advice, with a primary focus on regulatory processes within Europe, including European Medicines Agency (EMA) and Clinical Trials Information System (CTIS).
With experience in Regulatory Intelligence, eCTD template development, and Module 1 documentation support – including electronic Application Forms (eAF), Product Information, and Risk Management Plan (RMP) updates – Diede brings a thorough understanding of regulatory strategies to her role.
She holds a PhD in Hemato-pathology and both a Bachelorās and Masterās degree in Biomedical Sciences. Her academic expertise, combined with her industry experience, enables her to navigate regulatory landscapes and provide guidance to clients.
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