International Medical Device and IVD Consultants Since 1997
Consulting Specialties:
Quality Management
Assistance with FDA GMP and ISO 13485 implementation, quality system audits, Japan QMS compliance and 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 plus Japan, Australia, Canada and the United States.
Global Representation
In-country representation: European Authorized Representative, China Legal Agent, Japan Marketing Authorization Holder (MAH), US FDA Agent & 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. Today, more than 500 medical device companies worldwide trust Emergo to help obtain approval to sell their devices and maintain compliance with regulatory requirements.