Costa Rica Registration Holder for Device Companies
If you have no local office in Costa Rica, you must designate a Costa Rica Registration Holder to interact with the Ministry of Health and manage your approval process on your behalf. This is an essential step in registering your medical device for sale in
In-vitro Diagnostic (IVD) Regulations and Registration in Japan
Emergo assists medical device companies with registration for In-vitro diagnostics (IVDs) with expert knowledge, consulting and document preparation.
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Welcome to the website of Emergo Global Consulting LLC and its subsidiaries (collectively referred to herein as "Emergo").
QMS Compliance for Startup Medical Device Companies
Startups need a quality management system (QMS) for medical devices well before products are shipped. Emergo can help you comply with US FDA and European regulations so you don't run into problems during registration.
Local Authorized Representative for Medical Device Manufacturers
Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD manufacturers seeking global market access.
US FDA Electronic Medical Device Report (eMDR) Adverse Event Reporting for Medical Device Companies
Learn more about U.S. FDA Electronic Medical Device Report (eMDR) requirements for adverse event reporting for medical device manufacturers and initial importers.
EU MDR Compliance Consulting for Cosmetic and Aesthetic Products
Learn which cosmetic and aesthetic products fall under EU MDR requirements and how your company should prepare for MDR compliance.
Gap Analysis: EU MDD to MDR for Medical Device CE Marking
Emergo by UL's EU MDD to MDR 2017/745 gap analysis and strategy recommendations can help you make a smooth transition and avoid unforeseen challenges.
ISO 13485 Consulting and Implementation for Medical Device Manufacturers
ANSWERED ON THIS PAGE:
Why do we need ISO 13485 certification?
How will ISO 13485 certification benefit our company?
What is involved in the implementation process?