Programme

Welcome to LSA2022!
23th June 2022, 9 am to 4 pm, online
logo-life-science-nord
logo-fraunhofer-imte
logo-fraunhofer-mevis
logo-th-luebeck
logo-hic-luebeck

Regulatory affairs for medical devices

The EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are being implemented. We discussed the state of play, and give an outlook on further upcoming regulations, in particular for the use of health data. The session is organised by Life Science Nord’s Working Group on Regulatory Affairs.

Health data, interoperability, and data exchange

We will also highlight technological aspects of the exchange and use of health data in various environments: Medical devices linked in a 5G network or in an innovation hub for robotic surgery, and data collected in the European Health Data Space or an AI sandbox for the German Research Data Centre.
LSA2022 is an online conference.

Programme

08.50
Attendees‘ login
09.00
Welcome
Folker Spitzenberger, Conference chair, Centre for Regulatory Affairs in Biomedical Sciences (CRABS), Technische Hochschule Lübeck / Lübeck University of Applied Sciences & Fraunhofer IMTE, Lübeck
Session I: Regulatory Affairs
Session chair: Folker Spitzenberger
09.10
Keynote 1: Status of MDR and IVDR Implementation
Ortwin Schulte, Head of Unit “Medical Device Safety”, Federal Ministry of Health, Berlin
09.50
LIROS – Lübeck Innovation Hub for Robotic Surgery
Svenja Ipsen, Head of Business Unit “Operating Theatre Technology”, Fraunhofer IMTE, Lübeck
10.20
Ten-minute break
10.30
Regulatory Approach for Data Exchange, Distributed Alerting, and External Control of Medical Devices
Stephan Klöckner, OR.NET e.V., Herzogenrath and KEYMKR GmbH, Lübeck
11.00
Sustainable AI: The next big leap in quality and efficiency of radiology services
Naglis Ramanauskas, Chief Medical Officer, Oxipit, Vilnius, Lithuania
11.30
Ten-minute break
11.40
Panel discussion (I)
12.15
Bring your own lunch
Session II: AI & Deep Learning
Session chair: Dirk Hermsmeyer
13.00
Keynote 2: Giga for Health: Saving lives with 5G
Falko Schmid and Hug Aubin, Digital Health Lab, University Hospital Düsseldorf
13.40
AI / ML-based Tools in Radiology: A User's Point of View
Jörg Barkhausen, Director of Radiology, University Hospital Schleswig-Holstein, Lübeck
14.10
Ten-minute break
14.20
User Research: Expectations regarding an AI Sandbox for health claims data analyses
Markus Wenzel, Key Scientist Cognitive Computing, Fraunhofer MEVIS, Bremen
14.50
European Data Act and the European Health Data Space (EHDS): Opportunity or Threat for MedTech?
Pia Maier, Governmental Affairs Specialist, Medtronic GmbH, Berlin
15.20
Ten-minute break
15.30
Panel discussion (II)
16.00
End
Does it sound interesting? Then register now!