2500 Bee Cave Road, Building 1, Suite 300, 78746 Austin, TX
United States of America

Telephone +1 512 222-0262
Fax +1 512 327-9998

This company is co-exhibitor of
Messe Düsseldorf North America


Hall map

MEDICA 2016 hall map (Hall 16): stand D32-9

Fairground map

MEDICA 2016 fairground map: Hall 16

About us

Company details

Emergo 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, clinical consulting, auditing, ISO 14971 risk management, Green Dot consulting, CE Mark & medical distributor search.

JAPAN: PAL compliance, MAH representation, PMDA medical device approvals, Device Master Files, STED, reimbursement consulting, translations & medical distribution.

CHINA: CFDA 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.

BRAZIL: Medical device registration with ANVISA.

MEXICO: Medical device registration with COFEPRIS and Registration Holder service.

KOREA: MFDS medical device approvals and KGMP compliance.

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Company data

Sales volume

1-9 Mio US $

Export content

max. 75%

Number of employees




Area of business

Medical Services and Publications