The New EU Medical Device Directive Requirements For 2010: Is Your Company Ready?
13 November 2009
Hyatt Regency Santa Clara, Santa Clara, CA
With the March 2010 deadline fast approaching, many companies are scrambling to meet the new requirements of the revised EU Medical Device Directive (MDD). Join experts from KEMA for an interactive session that highlights the most critical changes to the EU MDD and addresses, in practical terms, the challenges firms are facing with their interpretation. Learn what the expectations are, from a Notified Body’s perspective, and gain practical insight into implementing the revised MDD.
This event is sponsored by the RAPS San Francisco Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals.
A luncheon will be available for all meeting registrants and participants may claim three RAC recertification points.
Friday, 13 November 2009
**10-11:30am – Special Morning Session: EU-MDD: A Primer (see below)
11:00am-12:00pm - Registration and Check-In
12:00pm–1:00pm - Networking and Luncheon
1:00pm–2:30pm - Presentation by Keith Morel, PhD, KEMA
2:30pm–3:00pm - Industry Panelist with Perspectives on Implementing the Revised EU MDD
3:00pm–3:30pm - Question and Answer Session
Location: Hyatt Regency Santa Clara
5101 Great America Parkway, Santa Clara, CA 95054
Directions can be found online, or by calling +1 408 200 1234
Registration Fee: RAPS members: $80.00 Nonmembers: $100.00
Register:
AM and PM Sessions: www.raps.org/personifyebusiness/Portals/0/Documents/RegForm_0921424b.pdf
Afternoon session only:
www.raps.org/PersonifyEbusiness/Portals/0/Documents/RegForm_0921424.pdf
Speaker: Keith Morel, PhD, is a senior project manager for KEMA Medical in Lafayette, CA. Morel is also a lead auditor for CE and ISO 13485:2003 audits (including CMDCAS) and performs Design Dossier reviews for clients. Prior to working for KEMA, Morel worked in R&D in the medical device industry as an engineer, manager and director, on various technologies including IVUS catheters and super-oxidized water products.
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Just Added==Special Complimentary Morning Session:
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The EU Medical Device Directive: A Primer!
10:00am–11:30am
Hyatt Regency, Santa Clara
We are pleased to offer a special pre-meeting workshop addressing the fundamentals of the EU Medical Device Directive. Whether you are new to medical devices, are preparing for the EU RAC Exam or would like a refresher before the afternoon presentation, we invite you to join us for this informative session.
Although there are no additional registration fees for this morning session, pre-registration is required. If you plan to attend both morning and afternoon sessions, use this special registration form.
Speaker: Craig J. Coombs, RAC, president of Coombs Medical Device Consulting, has more than 20 years of experience in the medical device industry. He has been a consultant since 1997 and is frequently called on to develop innovative US and European regulatory strategies; provide guidance in device failure analysis and procedures; and develop and implement transitional or crisis project management in the regulatory, clinical and/or quality arenas
CONTACTS:
Local Contacts: Michelle Ragozzino, PhD, RAPS SFChapter Chair: sfbayarearaps@gmail.com
RAPS Contact: Wesley Carr, +1 301 770 2920
