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What's Your Company's Future in the European Union (EU) in 2020?
Wednesday 13 March 2019, 04:30pm - 09:00pm
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Contact Rob Fleming

Orange County Regulatory Affairs Discussion Group (OCRA)
You are invited to an Evening Meeting 

 What’s YOUR Company’s Future in the European Union (EU) in 2020?
EU Medical Device Regulation (MDR) Requirements & Impact on YOUR Business

 

4.5 Hours Towards Your RAC Recertification
All OCRA Meetings Qualify For Recertification Hours

 

Hosts:
Hillary Keir, Senior Regulatory Affairs Associate, Allergan
Bonnie Safyurtlu, RAC, Director, Regulatory Affairs, Allergan

Program Managers:
Piet H. Lesage, Principal Consultant, GB5D, LLC
Janet Rubin-Halpert, RAC, CQE

Presenters:
Gabriele Howard, System Certifications Manager, NEMKO USA
Piet H. Lesage, Principal Consultant, GB5D, LLC
Christopher Mauch, Manager, Healthcare & Life Sciences Advisory, KPMG US
Anthony Rizzo, Assistant VP Medical Devices Development, BSI Regulatory Services
Royth von Hahn, PhD, Senior Vice President Medical & Health Services (Global), TÜV SÜD
Kim Walker, MS, RAC (US/EU), FRAPS, Global Regulatory, Quality & Clinical Consultant, Kim Walker Consulting

Synopsis:

Are YOU/YOUR Company prepared for the EU MDR?
What are EU MDR Requirements and what has CHANGED from the Medical Device Directive (MDD)? 
How do you determine the business impact of EU MDR on your organization and products and whether to remain in EU following EU MDR implementation?
Will EU MDR CE marking be worth it for some products?

Explore the regulatory, compliance, and business perspectives for a successful transition to EU MDR and the optimization of conformity to EU MDR for your products – so that YOUR Company has a future in the EU in 2020 and beyond! This engaging, dynamic program will focus on the requirements, business impact, and transition considerations of / for EU MDR. The program will feature subject matter experts on EU MDR. It also includes an intriguing case study for the group to review. 

Meeting Flyer:

For more details download the meeting flyer here.

 

 

Location Allergan - 2525 Dupont Drive - Irvine, CA 92612
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