Tue 4 June 2024, 12:30 - 18:00 Erasmus MC Na-2602, 3015 GD
Background
Since the ‘new’ Medical Device Regulations (MDR) are in place, software is also explicitly considered to be a medical device. As a consequence, the use of the in-house developed software in clinical care is subject to regulatory requirements and processes.
One of the motivations of performing (technologically oriented, software-based) research in a university medical centers is to, in the end, contribute to clinical care. The new MDR implies that results of potentially several years of research should undergo considerable (regulatory) assessment before in-house use can be granted.
Purpose
The main purpose of this symposium is to get informed on the MDR, it’s implications for research software, and to discuss whether (and how) medical device regulations should be taken into account in performing research in our field.
It is clear that following the complete QA and engineering requirements during research are way too much overhead for a PhD student. In addition, not all research and developments will end up in clinic. Can we take arrange our research process such that translation to clinic is facilitated in case clinical application is wanted? And can we, as researchers in the field of software and computer applications, also benefit from elements from the MDR? Could we for example benefit from more stringent engineering principles and QA during our research? And if so, how can we integrate that in our research? And if we want to translate our results to clinical practice, how can that be done? Or should we, as researchers, forget about translation, and leave that to commercial partners? It is around these questions that we looked for experts that may share their knowledge and experience.
Where and when
The symposium is organized by the ICAI Stroke Lab and the Imaging Office at the Department of Radiology & Nuclear Medicine of the Erasmus MC. Participation is free, but you should register (see link at bottom of this page). The symposium will be held on June 4th, 2024, at Na.26.02 in the Erasmus MC; the detailed program is as follows:
12:30-13:00: Walk-in and introduction
- 13:00-13:30: Kelly van der Geest/Sebastiaan Notenboom (MISO): MDR and software, what every researcher should know
- 13:35-14:05: Vincent van der Meer (MD Project): MDR from an external perspective, most important focus areas and pitfalls
- 14:10-14:40: Jan van den Brand (DataHub): MDR and the research process, how researchers can benefit from the MDR
14:45-15:15: Break/networking
- 15:15-15:45: Danny Ruijters (Philips, IGT systems): MDR and software development in a medical device company
- 15:50-16:20: Lisa Hoogendam (Rehabilitation): Translation of research software to clinic, an example from rehabilitation
- 16:25-16:55: Wilco Schillemans (Radiotherapy): Developing and maintaining in-house developed software for clinical care
17:00-18:00: Drinks/networking
You are very welcome to join this event! If you want to join, please register via this link, or by sending an e-mail.