Conference Program
08:00
Registration
08:50
Conference Opening & Welcome
Bassil Akra, Conference Chair
09:00
Session 1: General Requirements and Classification
09:00 - 09:30
MDR Implementation and Legal Requirements
Glenda Marsh
Senior Director, EMEA Regulatory Affairs, Johnson & Johnson, Switzerland
09:30 - 10:00
Changes in the Classification System
Elizabeth Gfoeller
Corporate Director Regulatory Affairs, MED-EL, Austria
10:00 - 10:30
Strategic Considerations for the Conformity Assessment
Bassil Akra
Founder and CEO Akra Team, Germany
10:30
Coffee Break, Networking and Visit the Exhibition
11:00
Workshop 1
Delegates will work in small groups to develop a medical device including classification and regulatory strategies.
Session will close with delegate presentations and feedback of their work.
12:30
Lunch Break, Networking and Visit the Exhibition
13:30
Session 2 – Conformity Assessment Plan
13:30 - 14:00
Labeling Changes under the MDR
Daniel Rubisoier
Regulatory Affairs Specialist, TÜV SÜD, Austria
14:00 - 14:30
Content of the Technical Documentation
Michael M. Kania
Founder and CEO, meddevo, Germany
14:30 - 14:45
EUDAMED Update (
Pre-Recorded)
Pre-Recorded) 
Richard Houlihan
CEO, EirMed, Belgium
14:45 - 15:00
UDI Requirements
Daniel Rubisoier
Regulatory Affairs Specialist, TÜV SÜD, Austria
15:00
Coffee Break, Networking and Visit the Exhibition
15:30
Workshop 2
Delegates will work in small groups to develop a draft IFU and draft TD structure for their developed device.
Session will close with delegate presentations and feedback of their work.
17:00
End of Day One
08:00
Registration
08:30
Session 3: Clinical Evaluation
08:30 - 09:00
Planning of the Clinical Evaluation Including Clinical Strategies
Rachel Mead
Clinical Regulatory Lead, BSI Group, UK
09:00 - 09:30
Relevant Aspects of a Scientifically Valid Literature Search
Shelley Jambresic
Senior Clinical Evaluation Manager, Geistlich Pharma, Switzerland
09:30 - 10:00
Medical Device Software and Cybersecurity
Erik Vollebregt
Partner, Axon Lawyers, Netherlands
10:00
Coffee Break, Networking and Visit the Exhibition
10:30
Workshop 3
Delegates will decide on the clinical strategy for their device based on the draft CEP.
Session will close with delegate presentations and feedback of their work.
12:00
Lunch Break, Networking and Visit the Exhibition
13:00
Session 4: Post-Market Requirements
13:00 - 13:30
PMS and Vigilance Requirements
Marco Turturici
Clinical & Regulatory Manager, MD-Clinicals, Switzerland
13:30 - 14:00
General and Specific PMCF Activities
Matthias Fink
Senior Clinical Consultant, Akra Team, Germany
14:00 - 14:30
PSUR and SSCP
Christoph Ziskoven
Clinical Expert Medical Devices, TÜV Rheinland, Germany
14:30
Coffee Break, Networking and Visit the Exhibition
15:00
Workshop 4
Delegates will decide develop a draft PMCF Plan, PSUR and SSCP for their example devices.
Session will close with delegate presentations and feedback of their work.
16:30
Conference Closing
