Zuzanna Kwade

Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research and clinical evaluation.

Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored MDCG2020-1 guidance on clinical evaluation of MDSW.

Training format

Topic

  • Next: 9-13 Jun 2025 Classroom

The Medical Device School - From Concept to CE Marking

Summer school

Classroom

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours Intensive
  • Presented by Zuzanna Kwade
  • Next: 30 Jun 2025 Live online
  • Also: 6 Nov 2025 Live online

AI & ML in Clinical Trials: Fundamentals, Applications, and Regulatory Aspects

New for 2025

Live online

AI and Machine Learning are revolutionising clinical trial data management by enhancing efficiency, streamlining processes, and minimising human error. This course will be of use in both the pharmaceutical and medical device industry.

  • 6 CPD hours
  • Presented by Zuzanna Kwade
  • Next: 13 May 2025 Live online
  • Also: 1 Oct 2025 Live online

Clinical Evaluation of Medical Device Software and Software as a Medical Device

Live online

This one-day course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices.

  • 6 CPD hours Focused
  • Presented by Zuzanna Kwade