International Medical Device and IVD Consultants Since 1997
Consulting Specialties:
Regulatory Compliance
Consulting for European CE Marking, Technical Files, FDA 510(k) clearance, STED, Japan PAL, China SFDA approvals, and Canadian licenses and other regulatory compliance issues.
Distribution Management
We help find and qualify medical distributors in Europe, including France, Germany, UK, Italy and Spain and other EU countries plus Japan, Australia, Canada and the United States.
Global Representation
In-country representation services: European Authorized Representative, China Legal Agent, Japan Marketing Authorization Holder (MAH), US FDA Agent and Australia TGA Sponsor.
Need help with international quality assurance, regulatory affairs and distribution management consulting? Emergo Group has been helping medical device and IVD companies access the world's largest medical device markets since 1997. More than 1,000 medical device companies worldwide have turned to Emergo to assist in obtaining approval to sell their devices and maintain regulatory compliance worldwide.
Attending Medica in Germany this November? Meet with us.