Meet...

Zuzanna Kwade

Presenter

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.

Zuzanna Kwade’s courses

Reviews for Zuzanna’s courses

Fantastic speaker and really interesting content. [Speaker] had a very broad knowledge and explained everything very clearly. Absolutely not an issue with a course, but was quite advanced for myself as a beginner. Recommended.

22 Jan 2025

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

This was a really insightful and helpful presentation which covered complex topics in a digestible format. Would recommend to anyone in this industry.

22 Jan 2025

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

This was one of the best webinars I followed recently. Very well presented, a lot of information and a very knowledgeable speaker.

22 Jan 2025

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

Great expertise, very engaging, practical presentation.

22 Jan 2025

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

Interactive sessions and opportunity for q and a's. Overall Very good.

22 Jan 2025

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

I wanted to learn more about clinical evaluations - different types, how to structure evaluations, and what regulatory requirements needed to be met. I learned all of this and much more; each topic was covered thoroughly, and I feel more educated and confident in these areas. The course was structured beautifully and presented very well. 10/10!

22 Jan 2025

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

Overall this course was excellent, and I found it extremely useful. I would highly recommend it. I wanted to understand the processes for developing compliant medical device software. I definitely got the necessary information to understand this better. Both excellent speakers and clearly extremely knowledgeable on the subject matter. Very impressive. I thought it would focus more on the development process (e.g. detail around how to implement EN 62304), but what this course demonstrated was that there is a lot more to consider. So that was a useful learning experience as well.

18 Nov 2024

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

[Speakers had] huge expertises. I accomplished what I wanted to achieve from this course.

18 Nov 2024

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

It was really good, both speakers tried to keep the audience attention with interactive tasks. As an overall view I am satisfied with the webinar and with the provided training materials, both with the shared information and the information quality.

18 Nov 2024

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Both speakers extremally knowledgeable and fantastic teachers. thoroughly enjoyed the course! Fantastic all around!

22 Jul 2024

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations