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
Live online
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Summer school
Live online, 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.
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.
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 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.