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 Representation
Global in-country representation for: European Authorized Representative, China Legal Agent, Japan Marketing Authorization Holder (MAH), US FDA Agent, Mexico Registration Holder and Australia TGA Sponsor.
Need help with international regulatory submissions, quality management or medical distribution management? Emergo Group has helps medical device and IVD companies access the world's largest medical device markets. More than 1,000 medical device and IVD companies from 40 countries worldwide look to Emergo for assistance with medical device regulatory compliance issues in North America, South America, Europe, Asia and Australia.
NEW! Emergo Group releases results of annual survey on the Outlook for the Medical Device & IVD Industry for 2010
