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From 510(k) consulting to QSR implementation, we can help you obtain FDA clearance for your medical device.
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Emergo has obtained CFS documents for many clients seeking medical device registration in Asian, Middle Eastern, and Latin American markets, and can procure a CFS on your behalf for your medical device.
In most major markets the path to medical device regulatory approval is well documented. The process may not be easy, but it is well understood. That’s not true in all countries, especially some countries in Latin America, Southeast Asia, Africa and the Mi
Medical device manufacturers selling products in the United States must comply with post-market reporting requirements outlined by the US Food and Drug Administration (FDA) and submit adverse events electronically to the FDA for review.
Emergo by UL offers FDA QSR consulting for medical device and IVD companies to help support successful 21 CFR Part 820 implementation and compliance.
FDA submission consulting services for medical device and IVD companies. Get help with US FDA registration from Emergo by UL.
Emergo by UL offers qualified in-country representative and regulatory representation for over 500 medical device companies worldwide.
ANSWERED ON THIS PAGE: What are the deadlines for ISO 13485:2016 certification? How should we approach the transition to ISO 13485:2016? What are the biggest changes in ISO 13485:2016?
ANSWERED ON THIS PAGE: What does ISO 14971 require? How do I implement ISO 14971? How do I apply the risk management system and concepts to my product?
Medical device and IVD registration with the Thai Food and Drug Administration (FDA). Get our local support for approval.
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.
ANSWERED ON THIS PAGE: What are the requirements for the Medical Device Single Audit Program (MDSAP)? Which countries are participating in the MDSAP? How can we achieve MDSAP certification?
ANSWERED ON THIS PAGE: 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?
Smart Builders walk you through regulatory documentation for Brazil’s Registro Route, Mexico Equivalency Routes, US FDA 510(k), and Europe’s MDD, MDR, and IVDR.
FDA 510(k) consulting for medical device submission and CDRH clearance. Learn about the FDA approval and the pre-market notification 510(k) submission process.
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.
ANSWERED ON THIS PAGE: Why does third-party FDA consulting make sense for some medical device companies?
ANSWERED ON THIS PAGE: What is an FDA Form 483? What are the next steps after getting an FDA Form 483? What is an FDA Warning Letter? How can you recover from an FDA 483 or Warning Letter?
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.