Company Profile Emergo - Medical Device Consulting 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.