International Medical Device and IVD Consulting
Consulting Specialties:
Regulatory Compliance
Regulatory consulting services for European CE Marking, Technical Files, US FDA 510(k) clearance, STED, Japan PAL compliance, China SFDA approvals, Canadian medical device licenses and COFEPRIS registration in Mexico.
In-Country Representative
Independent representation for: European Authorized Representative, Japan Marketing Authorization Holder (MAH), US FDA Agent, Australia TGA Sponsor and Registration Holder in Mexico, Brazil, China and Korea.
Need help with international medical device registrations, quality system compliance or medical distribution management? Emergo Group helps medical device and IVD companies access the world's largest medical device markets. More than 1500 medical device and IVD companies from 50 countries worldwide look to Emergo Group for assistance with international medical device regulatory compliance issues in North America, South America, Europe, Asia and Australia.
NEW! Emergo Group opens new office in Hamburg, Germany. Read more.
