Interview: Regulatory 4.0

Michael M. Kania
April 14, 2021
Medical Device Regulation

We spoke with Dr. Bassil Akra from Akra Team to learn more about the future of Regulatory Affairs, Quality Management and R&D. Digitalization is a must-have to meet the increasing requirements and at the same time stay competitive. Truly interesting to see this issue through the lens of a consultant who was previously working for a Notified Body.

Audio: German
Subtitles: English


  • Insights from a former Notified Body employee
  • Current problems
  • Manufacturers & Notified Bodies: "they also put on their trousers one leg at a time"
  • Structured Digitalization of RA/QA compared to IDMP/EMA Pharma world
  • Digital Future

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