EU Update:
Implementing New MEDDEV Guidance and Standards
Orange County Regulatory Affaris Discussion Group (OCRA)
Invites you to join us for a full day meeting.
See OCRA 3-6-13 Meeting Flyer for meeting details, directions and offline registration form.
Member Price: $200
Student/Government Discount: $105
Program Managers:
Gustavo Kobrin, President Strategic Regulatory Solutions, Inc.
Evelyn de La Vega, Global Regulatory Affairs Manager, Bausch + Lomb
Prerequisite:
This program is intended for individuals with a mid to high-level understanding of the European Directives concerning medical devices.
Synopsis:
In 2012 the adequacy of EU medical device controls was brought into question. The fraudulent activities of a medical device manufacturer, combined with overall concern over the age and adequacy of the Medical Device Directive have resulted in a renewed focus and proposed changes. The Medical Device Directive is under review to become a regulation. Notified Body methods and activities will change and therefore manufacturers will be impacted. The Year 2012 yielded:
• Many new or modified MEDDEV guidance documents
• Creation of the European Competent Authority’s Central Management Committee (CMC)
• Harmonization of key standards
• Proposed changes to the MDD and IVD Directives.
Please join us and our guest speakers for an informative and practical forum as we discuss the proposed and implemented changes and how these will impact you. Hear from industry speakers on effective ways to implement key guidance documents and standards.
Speakers:
John Bier, Operations Manager, Medical Devices NSAI
Kevin Corrigan, JD, Director of Regulatory Affairs, Advanced Sterilization Products
Mindy McCann, Vice President of Health Care, North America SGS
Christine Ruther, PE, President, C&R Engineering, Inc.
Helene Spencer, Consultant, ClinReg Consulting Services, Inc.
NOTE: If you are registering as a Student, you cannot use the online registration process. Please download the flyer and fax it back with your payment.
Please note that OCRA has an environment sustainability policy and hardcopies of presentations are not being distributed at meetings. Participants will instead receive speaker-approved electronic copies when available (which may be after the meeting).
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