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EUROPE 2021 AGENDA
28 - 29 September 2021 GMT+2 (CET)
Free (Pre-registration Required)
Online (Conducted via Zoom)
Day 1: 28 September 2021
09:00 – 09:15 AM
Introduction Day 1 & IMDS Overview
Monir El Azzouzi
Founder of Easy Medical Device & Partner of IMDS Europe
Jack Wong
Founder of ARPA & IMDS
May Ng
Founder of ARQon & IMDS
Global Regulatory Consultant
​
09:15 – 09:45 AM
European Medical Device Regulations (MDR): Immediate impact on Medtech companies
Jesús Rueda Rodríguez
Director General Strategies, Special Projects & International Affairs, Medtech Europe
​
09:45 – 10:15 AM
MDR: Legal ramifications
Erik Vollebregt
Lawyer, Axon Lawyers
​
10:15 – 10:45 AM
MDR: Perspectives and way forward from Notified Body
Martin Witte
Auditor, TÜV SÜD
​
10:45 – 11:15 AM
MDR: Challenges in Clinical Evaluations
Helene Quie
Consultant, Qmed Consulting
​
11:15 – 12:15 AM
IMDS Networking (Panel Discussion):
Commercialization - Bio Clusters in Europe/Asia
​
Chris Lo
Sr Service Promotion Manager, HKTDC
​
Jesús Rueda Rodríguez
Director General Strategies, Special Projects & International Affairs, Medtech Europe
​
12:15 – 12:30 PM
Closing
Jack Wong
Founder of ARPA & IMDS
​
Day 2: 29 September 2021
09:00 – 09:15 AM
Introduction Day 2 & EU Person Responsible for Regulatory Compliance (PRRC) and Swiss Representative Require​ments
Daniel Shoukier
Consultant of ARQon Medtech Europe​ GmbH
​
May Ng
Founder of ARQon & IMDS
Global Regulatory Consultant
​
09:15 – 09:45 AM
In Vitro Diagnostic Medical Device Regulations (IVDR)​: Performance Evaluation
Hakan Inan
Founder of Requalite GmbH​
​
09:45 – 10:15 AM
Brexit and Swixit​: Updates and impacts
Monir El Azzouzi
Founder of Easy Medical Device
Partner of IMDS Europe​
​
10:15 – 10:45 AM
EU MDR & IVDR​: Importance of independent importer
Edgar Kasteel
Founder of MedEnvoy​
​
10:45 – 11:15 AM
Interpretation of significant change during the grace period for manufacturers
Bassil Akra​
AKRA TEAM GmbH (Ex TÜV SÜD)​
​
11:15 – 11:30 AM
Closing​
Monir El Azzouzi
Founder of Easy Medical Device
Partner of IMDS Europe​