Directory of Study Group 4 Members

Canada - Industry

Mr Tim Missios (Acting Chair)
Boston Scientific ( Canada) Ltd
5060 Spectrum Way, Suite 500A
Mississauga, Ontario
CANADA L4W 5N5
Tel: 905-696-1819
Fax: 905-696-1830
e-mail: missiost@bsci.com

USA – Government

Ms. Jan Welch (Secretary)
Food and Drug Administration
Center for Devices and Radiological Health
2094 Gaither Road , HFZ-320
Rockville , MD 20850
UNITED STATES
Tel: 1-240-276-0354
Fax: 1-240-276-0114
e-mail: jan.welch@fda.hhs.gov

Canada - Government

Mr. Frédéric Hamelin
Health Canada, Medical Devices Bureau
RM 1605, Main Stats Building
150 Tunney's Pasture AL030IHI
Ottawa, Ontario
CANADA K1A0K9
Tel: 1-613-954-0387
Fax: 1-613-954-7666
e-mail: frederic_hamelin@hc-sc.gc.ca

United States - Industry

Ms. Elisabeth George
Philips Medical Systems
3000 Minuteman Road Building 1 - MS0101
Andover, MA 01810-1099
UNITED STATES
Tel: 1-978-659-4663
Fax: 1-978-659-4901
e-Mail: elisabeth.george@philips.com

United States - Government

Mr. Robert Ruff
Food and Drug Administration
10 Waterview Blvd, HFR-CE350
Parsippany, NJ 07054
UNITED STATES
Tel: 1-973-331-4916
Fax: 1-973-331-4969
e-mail: robert.ruff@fda.hhs.gov

Europe - Notified Body

Mr. John Worroll
CEC
c/o BSI
Maylands Avenue
Hemel Hempstead
UK – Herts HP2 4SQ
UNITED KINGDOM
Tel: 44-1442-230442
Fax: 44-1494-717654
e-mail: john.worroll@bsi-global.com

Europe - Notified Body

Mr. Stefan Preiss
CEC
TÜV SÜD Product Service GmbH
Ridlerstrasse 65
Munich 80339
Germany
Tel: 49-89-5008-4143
Fax: 49-89-5008-4108
e-mail: stefan.preiss@tuev-sued.de

Europe - Industry

Mr. Philippe Lartigue
Regulatory Affairs
Quality Assurance Safety & Regulatory
GE Medical Systems
283 rue de la Miniere
78533 BUC Cedex
FRANCE
Tel: 33-(0) 130-704-168
Fax: 33-(0) 130-704-440
e-mail: philippe.lartigue@med.ge.com

Europe - Industry

Mr. Bertram E. Koenig
Vice President Quality
B. Braun Medizintechnologie GmbH
Schwarzenberger Weg 73-79
34212 Melsungen
GERMANY
Tel: 49 5661 71-3561
Fax: 49 5661 75-3561
e-mail: bertram.koenig@bbraun.com

Europe – Industry

Dr. Francois Simondet
Air Liquide
75 Quai d’Orsay
75321 Paris Cedex 07
FRANCE
Tel. +33 1 40628527
Fax. +33 1 40628540
e-mail: francois.simondet@airliquide.com

Europe – Government

Mr. Rainer Edelhäuser
Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten
Sebastianstrasse 189
D-53115 Bonn
GERMANY
Tel.: +49 228 97794 12
Fax: +49 228 97794 44
e-mail: Rainer.Edelhaeuser@zlg.nrw.de

Japan - Industry

Mr. Shigetaka Miura
Senior Advisor
Sakura Seiki Co., Ltd.
3-1-9, Nikonbashi,
Honcho, Chuo-ku,
Tokyo 103-0023
JAPAN
Tel: +81-3-3270-1666
Fax: +81-3-3510-7517
e-mail: s.miura@sakurajp.com

Japan - Government

Mr. Akiko Hayashi
Office of Compliance
Compliance and Narcotics Division
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare
1-2-2 Kasumigaseki, Chiyoda-ku
Tokyo 100-8916
Japan
Tel: +81-3-3595-2436
Fax: +81-3-3501-0034
e-mail: hayashi-akiko@mhlw.go.jp

Japan – Government

Mr. Yuichi Miyamoto
Inspector
Office of Compliance and Standards
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku
Tokyo 100-0013
Japan
Tel: +81-3-3506-9446
Fax:+81-3-3506-9465
e-mail: miyamoto-yuichi@pmda.go.jp

Australia – Government

Dr. Dragana Milic
Therapeutic Goods Administration
PO Box 100
Wooden
ACT, 2606
AUSTRALIA
Tel: 61-2-6232-8412
Fax: 61-2-6232-8426
e-mail: dragana.milic@health.gov.au

Taiwan - Government

Mr. Albert T.W. Li
Industrial Technology Research Institute
321 Kuang Fu Rd. Section 2
Hsinchu 30042
TAIWAN
Republic of China
Tel: 886-3-573-2227
Fax: 886-3-573-2299
e-mail: alberttwli@itri.org.tw

Updated 2 July 2008

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