Medical device consultant training

Training/workshop for medical device consultants (§83 MPDG) with final examination and certificate

Contents:

• EU legal system for medical devices and in vitro diagnostic medical devices
• Medical Device Regulation (MDR) and InVitro Diagnostics Regulation
• Medical Devices Implementation Act (MPDG)
• Medical Devices Operator Ordinance (MPBetreibV)
• How does a product become a medical device/in vitro diagnostic medical device?
• Medical device consultant:in
• Collaboration with the PRRC/Article 15 Person (MDR)
• Market surveillance/post-market surveillance (MDR)

Short CV of the speakers:

Cornelius Weber is a trained healthcare and nursing professional and has successfully completed a bachelor's degree in medical technology. He is currently completing a distance learning programme in Regulatory Affairs at the Technical University of Lübeck. At the same time, he is supporting the leap:up regulatory affairs team as a working student.

Katja Krempler holds a doctorate in biology and has also completed the LifeScience Management course at ATV in Leipzig. She has many years of experience in quality management, regulatory affairs and the authorisation of medical devices. After working as a regulatory manager and QMB in a Leipzig start-up, she has been supporting start-ups and SMEs at leap:up since 2024 - focussing on quality management systems, technical documentation and regulatory issues.

Register here by 19 November 2025!

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