Market Data
Review general overview about medical device and IVD regulatory requirements by market and find helpful links to regulatory bodies that govern that market.
Press Releases
Read the latest press releases about Emergo by ULs' efforts to help make the world safer, more secure and more sustainable.
FDA Q-Sub Consulting and Pre-Sub Guidance for Medical Devices
Our US consulting team has extensive experience with the FDA Q-Sub process for medical devices. We can assist you with this critical step as part of the FDA clearance process.
FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers
Emergo by UL offers FDA QSR consulting for medical device and IVD companies to help support successful 21 CFR Part 820 implementation and compliance.
Extended MDR Date of Application: Optimizing Your PMS and Clinical Activities
In this one-hour webinar, we will focus on key compliance issues manufacturers should focus on in order to fully utilize the additional time granted before the MDR date of application.
Short Term or Part-time Medical Device QA/RA Outsourcing
Emergo provides short term quality assurance (QA) and regulatory affairs (RA) outsourcing for assistance with medical device registrations, QMS compliance, vigilance reporting and more.
Privacy Security Consulting for Medical Device, IVD Companies
Secure data management to meet HIPAA, GDPR requirements and achieve regulatory compliance
Certificate of Free Sale (CFS) for Medical Device Exports
Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries around the world.
South Korea KGMP Quality Management System Consulting
Emergo by UL offers KGMP quality system consulting for medical device companies selling in South Korea. We can help you comply with KGMP to register your medical device in Korea.
US FDA Medical Device Establishment Registration and FURLS Listing
FDA Establishment Registration