Emergo Group & EDM Services

January 8, 2009 — medical companies

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
USA

Phone: US office: +1 512 327 9997
Fax: US office: +1 512 327 9998
http://www.EmergoGroup.com
http://www.Medical-Distributors.com
http://www.FDA510k.com
http://www.AuthorizedRepresentative.com
http://www.GreenDotCompliance.eu
cs@emergogroup.com

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.

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