International Medical Device and IVD Consultants Since 1997
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 quality management, regulatory compliance and medical distribution management? 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 and IVD companies from 40 countries worldwide look to Emergo for assistance with medical device regulatory compliance issues.
NEW! Watch our 7 minute Flash presentation that fully explains the European CE Marking process. Requires audio.
