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

Moderator: Joanne Lee

Founder of MediHeroes & IMDS

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​