Satellite event on regulatory challenges
associated with in vitro diagnostic & medical device product development
Thursday afternoon, 29th of October 2020
The satellite event goes online too!
In addition to the Symposium in Point-of-Care Diagnostics, you have the opportunity to attend a half-day highly relevant satellite symposium focused on the regulatory challenges associated with in vitro diagnostic (IVD) and medical device product development.
The introduction of the new In Vitro Diagnostic Regulation (2017/746 EU) represents a major challenge for startups as well as established companies. Certification of new IVD products or re-certification of existing products will require major efforts placed in the Technical documentation and Clinical Evidence.
The symposium will cover specifically:
- Expert from Medidee Services giving an overview of IVD regulatory environment.
- Expert from Medidee Services discussing the issues of device software and smartphone apps used for diagnostic purpose.
- Representative from Notified Bodies sharing updates related to the assessment of the Technical Documentation, in particular Clinical Evidence.
- Representative from Competent Authority sharing his vision on the implementation of IVDR.
A round table discussion will be organized with experts and representatives from the Medtech industry, discussing the issues associated with the implementation of the new regulation. The audience will have the opportunity to ask direct questions to the panel.
The satellite symposium is a useful complement to the Swiss Symposium in Point-of-Care Diagnostics and is targeting MedTech RA/QA/CA professionals, MedTech innovating start-ups, and academics willing to get insights on preparing a smart transition to IVDR.
The registration of the satellite event is included in the online registration.
Dr. Silvia Anghel
Senior Associate | medidee (Lausanne, Switzerland)
Dr. Heike Möhlig-Zuttermeister
Technical Team Manager | BSI-NL (Frankfurt am Main, Deutschland)
Dr. Elena Lucano
Training Manager & Project Associate | medidee (Lausanne, Switzerland)
From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual. Classification of digital health tools is not trivial. Throughout the presentation we’ll find out more about software classification as IVD medical devices as well as software safety classification according to IEC 62304.
Elena holds a PhD in Electronic Engineer from the University of Rome Sapienza. During her PhD, she carried out her research activities at the Division of Biomedical Physics at the U.S. Food and Drug Administration (FDA) laboratories (OSEL / CDRH). She has a versatile experience on modeling and simulations, and conformity testing of medical devices to international standards. At Medidee, Elena manages projects related to regulatory and quality compliance and is also in charge of the CARAQA training programs running in Yverdon-Les-Bains, Basel and Louvain-La-Neuve.
Dr. Claudia Solimeo Meneghisse
Regulatory Affairs Manager| Tecan (Männedorf, Switzerland)