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Leading Solutions from Global Experts for the Approaching EU MDR

12.0
RAC Credits
Wednesday, 13 November 2019 (9:00 AM) - Thursday, 14 November 2019 (4:00 PM) Pacific Time (US & Canada)
2151 Laurelwood Rd
Santa Clara, California, USA, 95054-2754

With just over 6 months to go before the date of application of the EU MDR 2017/745, manufacturers need to have strategies and action plans in place to meet the requirements and challenges posed by this new regulation. This event will tackle the detailed “how to” questions manufacturers may have across many of the MDR hot topics. It will not address clinical data and evaluation, as that is very detailed and being hotly debated; This will clear the way to focus on the many other detailed issues manufacturers may have such as Economic Operators, Systems and Procedure Packs, Labeling/IFU/Implant Card, EU UDI requirements and practice, PMS and trend reporting (Art. 88), Art. 117 and drug-device combination products, Software, Hazardous Materials and Changes that can be made during the Soft Transition. Several Notified Body experts will also be on hand to give an overview of more general status and preparations (including Brexit, Eudamed, Harmonized Standards, CS, class Ir etc.) and participate with the other speakers in an open Q&A session.

This workshop is aimed at the mid-level regulatory affairs professional who is responsible for applying the EU MDR requirements to his/her organization’s products. Knowledge of the MDD is not required but does help provide a better understanding. Basic knowledge of the requirements of MDR would be beneficial, as would real-world challenges and issues posed by implementing the MDR requirements within their own organization



Registration Closes:  6 November 2019

Refund Deadline:  14 October 2019

RAC Credits:  12 (Upon attending and completing the program)


Will the meeting be recorded?  No


Registration to 14 October 2019

MEMBER:    $1050

NONMEMBER:    $1150


Registration from 15 October to 6 November 2019

MEMBER:    $1150

NONMEMBER:    $1250

NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.


Program Schedule


Wednesday, 13 November (9:00am–5:15pm)

  • Economic Operators 
  • Group Exercise
  • Systems and Procedure Packs
  • Labeling and IFU (GSPR 23)
  • Implant Card (Article 18)
  • UDI
  • Eudamed
  • Group Exercise

Thursday, 14 November (9:00am-5:00pm)

  • Article 88 - Trend Reporting
  • Article 117 and Drug Device Combination Products
  • Software Under MDR
  • General Update by NBs
  • Article 120(3) and Changes in the Soft Transition
  • Hazardous Materials

NOTE: The agenda may vary based on changing requirements.


Faculty (additional faculty announced at a later date)

  • Emma Brennan, Claigan
  • Lena Cordie-Bancroft, president, Qualitas Professional Services, LLC
  • Keith Morel, PhD, vice president regulatory compliance, Qserve Group US, Inc.
  • Tony Rizzo, assistant vice president, medical devices - development, BSI Group 
  • Norbert Stuiber, TUV SUD America, Inc.
  • Royth Von Hahn, vice president of medical health service, TUV SUD America, Inc. 

Workshop Location

Biltmore Hotel and Suites

2151 Laurelwood Road

Santa Clara, CA 95054


Accommodation Options

Below is a list of nearby hotel properties near host venue.


Towne Place Suites by Marriott San Jose

2877 Lakeside Drive

Santa Clara, CA 95054


Embassy Suites by Hilton Santa Clara Silicon Valley

2885 Lakeside Drive

Santa Clara, CA 95054


The Plaza Suites Hotel Silicon Valley

3100 Lakeside Drive

Santa Clara, CA 95054


Cancellation

All requests for cancellation must be received in writing or by calling customer service by 14 October. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified.

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to raps@raps.org. Substitutions may be accepted with written approval from RAPS by 30 October.


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.


Questions?

Call RAPS Solutions Center at +1 301.770.2920, Ext 200


Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.


Registration Form

If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.


Program Contact

Nichelle Sankey

nsankey@raps.org

+1 301 770 2920, Ext 291

Register