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.