Implementing the European MDR with Focus on Clinical and Supply Chain/Economic Operators

When:  Aug 24, 2018 from 8:00 AM to 5:00 PM

Friday, 24 August 2018
8:00 am–5:00 pm PDT
Crowne Plaza San Jose-Silicon Valley
777 Bellew Drive
Milpitas, CA 95035
+1 408 321 9500

On 5 May 2017, the European Commission officially published the Medical Device Regulations (MDR) 2017/745 in the Official Journal of the European Union (OJEU). The MDR replaces the Active Implantable Medical Devices Directive (90/385/EEC) and the Medical Devices Directive (93/42/EEC). The deadline to comply with the new regulations is 26 May 2020.

Come learn from our expert panel of industry representatives who have been personally involved in implementing the MDR at their organization.  You’ll leave this experience with practical tips and tools needed to effectively transition to the MDR based on their lessons learned. 

Scheduled presentations will include:

  • Summary of Key MDR Changes
  • Implementing the MDR Supply Chain and Economic Operators in Practice
  • Implementing the MDR Clinical Data Evaluation Requirements in Practice
  • Managing Global, Cross-Functional Interactions for a Successful MDR Implementation

Speaker bios and the full program agenda are available for review.

Don’t miss out on this unique opportunity to hear from industry experts on this important topic while connecting with others from your region. This event is brought to you by the RAPS San Francisco Bay Area Chapter and is intended to facilitate networking and knowledge sharing amongst those in the local regulatory community. RAC holders can claim six RAC recertification credits.

Speakers and Panelists:
Keith Morel, vice present of regulatory compliance, QServe
Tim Ehr, Integrated Project Management Company (IPM)
Nancy B. Lowe, process champion for clinical evaluation reports, W.L. Gore & Associates
Nicolas Pugliano, regulatory affairs associate, W.L. Gore & Associates

Registration Information:
RAPS Members:  $175
Nonmembers: $200


777 Bellew Dr
Milpitas, CA 95035-7900