This document lists the attendees of the AdvaMed 510(k) Submissions Workshop held in Washington, D.C. on October 15-16, 2018. It includes over 80 names, job titles, and companies of individuals in regulatory affairs, quality assurance, engineering, and legal roles from medical device and diagnostic companies, as well as representatives from the FDA and industry associations.
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AdvaMed 510(k) Submissions Workshop Attendees
1. 1
AdvaMed 510(k) Submissions Workshop
Grand Hyatt Washington
Washington, DC
Oct. 15-16, 2018
List of Attendees
Dylan Alu
Badge Name: Dylan
Regulatory Affairs Specialist
Neuronetics
Malvern, PA
Betsy Anda-Harris
Badge Name: Betsy
Team Leader
Ortho Clinical Diagnostics, Inc.
Raritan, NJ
Raul Arevalo
Badge Name: Raul
Sr. Regulatory Affairs Specialist
Medtronic Neurosurgery
Goleta, CA
Noelle Bagnall
Badge Name: Noelle
Vice President, Business Development
eLum Technologies, Inc
Fremont, CA
Pragnya Bakka
Badge Name: Pragnya
Regulatory Affairs Specialist
Zimmer Trabecular Metal
Technology
Parsippany, NJ
Ganesh Balachandar
Badge Name: Ganesh
Regulatory Affairs Specialist
Microvention Inc.
Aliso Viejo, CA
Jennifer Bennett
Badge Name: Jen
Sr. Analyst, Regulatory Affairs
Beckman Coulter, Inc.
Chaska, MN
Medha Bharadwaj
Badge Name: Medha
Regulatory Affairs Specialist
FUJIFILM SonoSite, Inc.
Bothell, WA
Cindi Brooks
Badge Name: Cindi
Manager, Meetings & Conferences
Advanced Medical Technology
Association
Washington, DC
Nicolette Cannella
Badge Name: Nicki
Specialist, Regulatory Affairs
Abbott
Fort Worth, TX
Kimberly Carden
Badge Name: Kim
Rotation Associate
Integra LifeSciences Corporation
Plainsboro, NJ
Aditi Chaubal
Badge Name: Aditi
Regulatory Affairs Specialist
FUJIFILM SonoSite, Inc.
Bothell, WA
2. 2
Lindsay Clayboss
Badge Name: Lindsay
Regulatory Associate I
Medcomp
Harleysville, PA
Tammy Dean
Badge Name: Tammy
Regulatory Affairs Elecsys Manager
Roche Diagnostics Operations,
Inc.
Indianapolis, IN
Angela Demarco
Badge Name: Angela
Biomedical Engineer
U.S. Food and Drug Administration
Silver Spring, MD
Mary Dockery
Badge Name: Mary
Regulatory Affairs Specialist
BIOTRONIK, Inc.
Lake Oswego, OR
Benjamin Dollins
Badge Name: Ben
Regulatory Affairs Specialist
Boston Scientific Corporation
Saint Paul, MN
Sean Fallon
Badge Name: Sean
Rotational Associate
Integra LifeSciences Corporation
Plainsboro, NJ
Teri Feeley
Badge Name: Teri
Regulatory Specialist
Acelity
San Antonio, TX
Kate Fink
Badge Name: Kate
Project Manager
Martech Medical Products, Inc.
Harleysville, PA
Elizabeth Garza
Badge Name: Liz
Regulatory Affairs Specialist II
Acelity
San Antonio, TX
Clayton Ginn
Badge Name: Clayton
Regulatory Technical Specialist
Siemens Healthcare, Molecular
Imaging
Knoxville, TN
Seiko Hamada
Badge Name: Seiko
Olympus Corporation
Tokyo, Japan
John Hao
Badge Name: John
Rotation Associate
Integra LifeSciences Corporation
Plainsboro, NJ
Joshua Hubbard
Badge Name: Josh
Sr. Project Engineer Manager
RK Manufacturing Corporation
Danbury, CT
Danielle Humphrey
Badge Name: Danielle
Counsel
Hogan Lovells US LLP
Washington, DC
Nathaniel Ivey
Badge Name: Nathan
Regulatory Health Project Manager
U.S. Food and Drug Administration
Silver Spring, MD
Rachel Johnson
Badge Name: Rachel
Marketing Manager
Advanced Medical Technology
Association
Washington, DC
3. 3
Angela Johnson
Badge Name: Angie
Regulatory Affairs Specialist II
ACIST Medical Systems
Eden Prairie, MN
Sammie Joseph-Fredericks
Badge Name: Sammie
Sr. Regulatory Affairs Specialist
Medtronic
Mounds View, MN
Marium Khalid
Badge Name: Marium
Rotational Associate
Integra LifeSciences Corporation
Plainsboro, NJ
Zarnain Khan
Badge Name: Zarnain
Regulatory Submissions Specialist
Varian Medical Systems, Inc.
Palo Alto, CA
Jisun Kim
Badge Name: Ji
Quality, Regulatory, and Operations
Rotation Associate
Integra LifeSciences Corporation
Plainsboro, NJ
Courtney Kleist
Badge Name: Courtney
Regulatory Affairs Specialist
Abbott
St. Paul, MN
Amy LaBarre
Badge Name: Amy
Director of Quality
RK Manufacturing Corporation
Danbury, CT
Tran Le
Badge Name: Tran
Quality, Regulatory Affairs, and Global
Operations Rotational Associate
Integra LifeSciences Corporation
Plainsboro, NJ
Jonathan Lee
Badge Name: Jonathan
Regulatory Affairs Specialist
Freudenberg Medical
Carpinteria, CA
Jonathan Lendrum
Badge Name: Jonathan
Regulatory Affairs Consultant
Fang Consulting, Ltd.
Minneapolis, MN
Cecilia Lopez
Badge Name: Cecilia
Manager, Marketing - Conferences &
Events
Advanced Medical Technology
Association
Arlington, VA
Michael Lorenz
Badge Name: Michael
Senior Analyst, Regulatory Affairs
Beckman Coulter, Inc.
Chaska, MN
Nicole Lyden
Badge Name: Nicole
Sr. Regulatory Affairs Specialist
Boston Scientific Corporation
Saint Paul, MN
Mia McCorkel
Badge Name: Mia
Regulatory Affairs Specialist
Stryker Sustainability Solutions
Tempe, AZ
Nan McIntosh
Badge Name: Nan
Regulatory Affairs Specialist
FUJIFILM SonoSite, Inc.
Bothell, WA
Catherine McNally
Badge Name: Catherine
Senior Regulatory Affairs Specialist
Stryker Instruments
Portage, MI
4. 4
Kelsey Moser
Badge Name: Kelsey
Regulatory Affairs Associate
Arthrex Inc.
Naples, FL
Walter Murray
Badge Name: Walt
Strategic Partner
MasterControl Inc.
Salt Lake City, UT
Anita Nemeth
Badge Name: Anita
Sr. RA Analyst
B. Braun Medical Inc.
Allentown, PA
Yen Nguyen
Badge Name: Yen
Principal Regulatory Affairs Specialist
Cepheid
Sunnyvale, CA
Diana Osgood
Badge Name: Diana
Sr. Regulatory Affairs Specialist
Medcomp
Harleysville, PA
Jackie Perri
Badge Name: Jackie
RA Specialist
Stryker Corporation
Mahwah, NJ
MARY PRUNTY
Badge Name: Mary
Regulatory Affairs Manager
VISTAMED LTD
CARRICK ON SHANNON, Ireland
Shahla Riazi
Badge Name: Shahla
Consumer Safety Officer
U.S. Food and Drug Administration
Silver Spring, MD
Rita Ricker
Badge Name: Lauren
Regulatory Affairs Specialist
Zimmer Biomet
Warsaw, IN
Ekaterina Shanina
Badge Name: Ekaterina
Regulatory Affairs Specialist
Varian Medical Systems Oncology
Division
Palo Alto, CA
Patricia Shrader
Badge Name: Pat
Senior Counsel
Hogan Lovells US LLP
Washington, DC
Jody Stoughtenger
Badge Name: Jody
Sr. Specialist, Regulatory Affairs
Fresenius Kabi USA, LLC
Lake Zurich, IL
Bryant Tate
Badge Name: Bryant
Senior Regulatory Affairs Professional
Abbott Diagnostics
Irving, TX
Ifeanyi Uwemedimo
Badge Name: Ifeanyi
Biomedical Engineer
U.S. Food and Drug Administration
Silver Spring, MD
Micaela Victoria
Badge Name: Micaela
Regulatory Affairs Specialist II
Penumbra, Inc.
Hayward, CA
Amit Vora
Badge Name: Amit
Integra LifeSciences Corporation
Plainsboro, NJ
5. 5
Rong Wang
Badge Name: Joyce
QARA VP, Medtronic Greater China
Medtronic China
Shanghai, China
Jauna Werner
Badge Name: Jauna
VP-Supply Chain and Quality
Securisyn Medical
Highlands Ranch, CO