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.
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, Classroom
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.