Emergo Group & EDM Services

Phone: EU office: +31 70 345 8570
Fax: EU office: +31 70 346 7299
1705 S. Capital of Texas Hwy Suite 500
78746 Austin, Texas

Phone: US office: +1 512 327 9997
Fax: US office: +1 512 327 9998

Company Contacts
Department/ Name Address

Emergo Europe Molenstraat 15, 2513 BH, The Hague, The Netherlands
Patrick Braster – pb@emergogroup.com

Emergo Group Inc. HEADQUARTERS:, 1705 S. Capital of Texas Hwy, Suite 500, Austin, Texas 78746 USA
Chris Schorre – cs@emergogroup.com

Emergo Japan K.K. Ichigaya Green, Plaza #031, 3-4-2 Ichigaya Sadoharacho, Shinjuku-ku, Tokyo 162-0842, Japan
Michiharu Miyahara – mmiyahara@emergogroup.com

Medical Distributor Search – EDM Services 1705 S. Capital of Texas Hwy, Suite 500, Austin, Texas 78746 USA
Michael van der Woude – mvdw@emergogroup.com
Company Figures
Number of employees 20-49
Sales volume 1-9 Mio US $
Export content > 75%
Year of foundation 1997
Area of business Services and Publications

Language: German Language: English Company Profile

Emergo Group – Medical Device Consultants
Emergo Group consultants have helped medical device and IVD companies obtain regulatory approval to sell their products worldwide since 1997. Services include:

UNITED STATES: FDA 510(k) approvals, FDA GMP quality systems, medical distributor search, FDA US Agent, medical device QSR training, 513(g) & FDA 483 response.

EUROPE: CE Marking consulting, ISO 13485 implementation, Authorised Representative, Technical File preparation, auditing, ISO 14971 risk management, Green Dot consulting, CE Mark & medical distributor search.

JAPAN: PAL compliance, MAH representation, new medical device approvals, Device Master File creation, STED, reimbursement consulting, translations & medical distribution.

CHINA: SFDA approvals, Legal Agent representation, CCC Mark certification & clinical trial (CRO) consultants.

CANADA: Medical Device License (MDL) approval, Canadian Medical Device regulations & ISO 13485:2003 consulting.

AUSTRALIA: TGA Sponsor representation & new device registration.

Emergency Medical System Poland Sp. z o.o.
EMED T. Jakubik R. Mazurek Sp.J.
EME S.r.l.
EMD Medical Technologies

EMG Technology Co., Ltd.
Empecs Medical Device Co., Ltd., Tianjin
Emperor Electronic Technology Co., Ltd., Shenzhen
EMS Electro Medical Systems S.A.