Meet...
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.
New for 2025
Live online
Live online
Live online
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
Cookies: we use cookies to deliver the best experience to you and to help us understand our customers.
We set the following types of cookies; please set your preference as to which you consent to accepting:
Read our cookie policy
These cookies are essential to correct operation of the website, such as allowing you to log in and purchase. They are used only on this site.
We use Google Analytics and similar platforms to allow us to better understand the type of visitors to our site and their activity. Enabling this should not shape or alter your browsing experience on other websites.
Marketing cookies help us to be more targeted with our online advertising to deliver more relevant content. Enabling this may make you more likely to see adverts from us on other websites.