International Medical Device and IVD Consultants Since 1997

Services by Region:

Consulting Specialties:

Quality Management

Assistance with US FDA Quality System Regulation and ISO 13485 consulting, QMS audits, Japanese quality system requirements, internal auditor training and other quality assurance services.

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.