Course overview
Whether developing new medical software for more precise diagnosis and targeted treatment or a healthcare app for individuals concerned about their health, manufacturers are tasked to appreciably prove to authorities the safety, quality, and effectiveness of their products. The evaluation of clinical safety and performance, as well as the overall benefit‑risk profile of the product, through a critical assessment of relevant data, is one of the key requirements for the manufacturers of a medical device software and a focus area for regulators.
This course will provide a clear understanding of the the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices. It will also provide advice on how to determine the type and amount of data needed to sufficiently support the intended medical purpose and (individual) clinical claims, with many practical examples and analysis of differences between EU MDR and FDA approach.
CPD Hours: 6
Course Content
- Day 1
- Introduction to clinical evaluation
- How to define a scope and a level of clinical evidence for medical device software
- Case studies - clinical evaluation of medical device software
- Clinical trials and validation studies
- Clinical trials and validation studies - continued
- Clinical evaluation post-market
Speakers
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.
