United States
From 510(k) consulting to QSR implementation, we can help you obtain FDA clearance for your medical device.
European Union
We are experts in European medical device and IVD compliance. We'll help you navigate regulatory changes in the EU.
US FDA Consulting for Medical Device and IVD Manufacturers
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Why does third-party FDA consulting make sense for some medical device companies?
Medical Device UDI (Unique Device Identification) Consulting and Training
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How does the US FDA UDI system work?
When must we comply with UDI system requirements?
Which device classifications need to comply with UDI requirements?
US FDA Medical Device Classification
The US Food and Drug Administration (FDA) uses this system to classify medical devices as Class I, II, or III based on increasing risk to the patient or user.
Clinical Evaluation Reports (CER) for Medical Devices
Compliance support for Clinical Evaluation Reports (CERs), Revision 4 standards and EU Medical Devices Regulation (MDR 2017/745).
Brazil Registration Holder Service for Medical Device and IVD Companies
Learn what it means to choose Emergo by UL as your independent Brazil Registration Holder (BRH) for foreign medical device companies selling in Brazil.
EU MDR Classification of Medical Devices
Learn the EU MDR classification of medical devices and deepen your understanding of the European CE marking regulatory process with our regulatory consulting.
Canadian CMDR Consulting for Health Canada Medical Device Registration
CMDR Regulatory Strategy
US FDA Official Correspondent for Medical Device Companies
Emergo by UL provides US Agent services to more than 300 medical device companies, so we know how to handle correspondence with the FDA.