1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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Mr Carlos Arglebe
Quality Management & Regulatory Affairs
Siemens AG, Medical Solutions
Henkestrasse 127
Erlangen D-91052
GERMANY
Tel: 49 9131 84 2877
Fax: 49 9131 84 6555
e-mail: carlos.arglebe@siemens.com
Dr. Dirk Wetzel
Head, Medical Device Division
Bundesinstitut für Arzneimittel und Medizinprodukte
Federal Institute for Drugs and Medical Devices
Abteilung Medizinprodukte / Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
GERMANY
Tel.: +49 - 228 - 207 - 5235
Fax: +49 - 228 - 207 - 3894
E-mail: wetzel@bfarm.de
Mr. Egan Cobbold MSc, Chair
Quality Systems Officer
Medical Devices Bureau
150 Tunney’s Pasture Driveway , Room 2605
Tunney's Pasture, PL 0301H1
Health Canada
Ottawa, Ontario
K1A 0K9
CANADA
Tel: 1-613-954-4597
Fax: 1-613-946-6758
e-mail: Egan_Cobbold@hc-sc.gc.ca
Mr. Gunter Frey, Vice-Chair
National Electrical Manufacturers Association
c/o GE Healthcare
3000 N. Grandview Blvd. - Mail Stop W-440
Waukesha, WI 53188-1696
UNITED STATES
Tel: 1 262 548 2852
Fax: 1 414 908 9363
e-mail: gunter.frey@med.ge.com
Mr. Hideki Asai
Regulatory Compliance Office
Strategic Planning Division
Life Science Business Group
Hitachi High-Technologies Corporation
24-14, Nishi-Shinbashi 1-chome, Minatoku
Tokyo, 105-8717
JAPAN
Tel: 81-3-3504-5836
Fax: 81-3-3504-7756
e-mail: asai-hideki@nst.hitachi-hitec.com
Mr. Jan Noupbaev, M. Sc., CQE, CQA, RAC
Compliance / Regulatory Affairs
Medtronic of Canada Ltd.
6733 Kitimat Rd ,
Mississauga , ON
L5N 1W3
CANADA
Phone (905) 816-5278
Fax (905) 826-6620
e-mail: jan.noupbaev@medtronic.com
Mr. Kenneth F. Kopesky
AdvaMed
c/o Medtronic Inc.
710 Medtronic Parkway
LC270
Minneapolis, MN 55432-5604
UNITED STATES
Tel: 1 763 505 2568
Fax: 1 763 505 2613
e-mail: ken.kopesky@medtronic.com
Dr. Ken Nicol
Regulatory Affairs Manager
St. Jude Medical Australia Pty Ltd.
Level 1, 290Burns Bay Rd.
Lane Cove
NSW 2066
AUSTRALIA
Tel: 61 2 9427 5100
Fax: 61 2 9427 6500
e-mail: knicol@sjm.com
Mr. Keith M. Smith BE MBiomedE
Quality System Manager
Manufacturers Assessment Branch
Therapeutic Goods Administration
Symonston, ACT 2609
AUSTRALIA
Tel: +61 (0) 2 6232 8316
Fax: +61 (0) 2 6232 8426
e-mail: keith.m.smith@tga.gov.au
Mrs. Kimberly Trautman MSc
Center for Devices and Radiological Health
Food and Drug Administration
2098 Gaither Rd.
Rockville
MD 20850
UNITED STATES
Tel: 1 301 594 4648
Fax: 1 301 594 4672
e-mail: kimberly.trautman@fda.hhs.gov
Mr. Munehiro Nakamura
Manager, Medical Devices Division
Kaneka Corporation
3-2-4, Nakanoshima, Kita-ku,
Osaka , 530-8288
JAPAN
Tel:+81-6-6226-5141
Fax:+81-6-6226-5143
e-mail: Munehiro_Nakamura@kn.kaneka.co.jp
Mr Shinichi Takae
Deputy Director,
Office for Compliance
Compliance and Narcotics Division
Pharmaceutical and Food Safety Bureau,
Ministry of Health, Labour and Welfare (MHLW)
1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-8916
JAPAN
TEL:+81-(0)3-3595-2436
FAX:+81-(0)3-3501-0034
E-mail: takae-shinichi@mhlw.go.jp
Dr. Victor Dorman-Smith
EUCOMED
15 Marymount, Pearse Road
Sligo
IRELAND
Tel: 353 71 91 53850
Fax: 353 71 91 53850
e-mail: victor.dorman-smith@abbott.com
Updated 20 December 2007
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