US FDA Agent Representation for Medical Device and IVD Companies
Appoint Emergo as your registered US FDA Agent representation and learn about our responsibilities as the liaison between your medical device or IVD company and the FDA.
Australian TGA Sponsor for Medical Device Companies
Learn about what Emergo by UL can provide as your TGA Sponsor for Australia and what it means for us to act as a representative for medical device and IVD companies.
Medical Device Registration in Peru
Emergo by UL can help you register your medical device in Peru, including preparing and submitting the required registration materials to DIGEMID standards.
SFDA Medical Device Registration in Saudi Arabia
Emergo by UL can assist you with gaining medical device marketing authorization (MDMA) approval from the Saudi Food and Drug Authority (SFDA).
Medical Device Post-market Surveillance
Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.
Health Canada Medical Device License and MDEL Registration Consulting
Learn about the regulations surrounding Medical Device Establishment Licenses (MDEL) and the process for MDL registration and approval with Health Canada.
Quality Management System (QMS) Audits for Medical Devices
We conduct ISO 13485 pre-certification and FDA QSR (21 CFR 820) compliance audits for medical device companies.
About
Regulatory Affairs and Quality Assurance experts dedicated to helping medical device and in-vitro diagnostics manufacturers explore and expand into new markets.
Medical Device Regulatory Pathway Support for Smaller International Markets
From Algeria to Zambia, we provide custom Regulatory Pathway Reports for almost every country in the world, including Latin America, Southeast Asia, and Africa.
Medical Device and IVD Regulatory Affairs and Quality Consulting
With help from Emergo’s medical device RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements worldwide.