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Organization of Regulatory and Clinical Associates
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Organization of Regulatory and Clinical Associates
P.O. Box 3490
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HomeCurrent/Future EventsRequirements in the EU MDR That Go Beyond ISO 13485:2016

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Requirements in the EU MDR That Go Beyond ISO 13485:2016

When:
Wednesday, April 17, 2019, 8:00 AM until 10:00 AM
Where:
Watertown Hotel - U District
(Speaker will be presenting remotely)
Venue website
4242 Roosevelt Way NE
Seattle, WA  98105

(206) 826-4242
Category:
Regular Monthly Meeting
Registration is recommended
Payment In Advance Or At Event
RSVP by Thursday, April 11, 2019
Registration: 7:30 a.m. – 8:00 a.m. PST
Meeting: 8:00 a.m. – 10:00 a.m. PST

PAID FEES ARE NON REFUNDABLE.

PARKING - Free underground parking. No parking pass required. Attendees are to buzz the intercom to be let into the parking lot.

Credit card payments can only be accepted online prior to the meeting. If you plan on paying at the door, please note that the Registration Team can only accept CASH or CHECKS.
No Fee
$60.00

SPEAKER WILL BE PRESENTING REMOTELY


TOPIC: Requirements in the EU MDR That Go Beyond ISO 13485:2016

TOPIC DESCRIPTION: Even though the new EU Medical Device and InVitro Diagnostic Regulations published in May of 2017, do not expressly change the Quality Management System (QMS) requirements and ISO 13485:2016 is still recognized as an acceptable European Standard, there are significant upgrades that every manufacturer wishing to market in Europe will have to ensure within their QMS.

SPEAKER: Kimberly A Trautman, EVP Medical Device International Services, NSF International (presenting remotely)

SPEAKER BIOGRAPHY: Experienced Medical Devices and InVitro Diagnostics Executive
Vice President with 26 years of working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes medical device regulatory services and recently developed a formal Education/Training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation.

Recognized International Expert in global medical device regulations, wrote and harmonized the US FDA Quality System Regulation 21 CFR § 820 and was on the international authoring group of ISO 13485 since inception. While at US FDA conceived and developed the MDSAP international consortium of five Global Regulators, as well as its many foundational documents. Twenty year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Medical Device expert on the Center for Drug Evaluation and Research (CDER) “GMPs for the 21st Century Initiative” Steering Committee and on the FDA authoring group for the Combination Product Good Manufacturing Practice (GMP) Part 4 regulation. Kim last position at CDRH was Associate Director for International Affairs within the Office of the Director.

Currently at NSF International in the Health Sciences Division, Kim is leveraging her over thirty years of medical device sector experience to expand international regulatory affairs and compliance services for NSF International global clients.


WHO: Clinical, regulatory, quality, manufacturing and legal

This meeting includes:
- Coffee and tea
- Pastries and fresh fruit


Attendance at this meeting may be applied as 1.5 points towards RAC re-certification