Let us help file your 510k application.
Who needs 510k 
Overview of who needs a FDA 510k application and how to determine if your medical device qualifies.
Approval process
How the FDA 510(k) clearance process works and what to expect during the application process.
Why hire us?
Why you should hire Emergo Group to prepare and submit your 510k application to the FDA.
Costs
Overview of FDA 510(k) application fees and how we charge to prepare your 510(k) application.
Emergo Group specializes in quality assurance and regulatory affairs consulting for medical device companies worldwide. We have successfully submitted more than one hundred FDA 510(k) applications to the US Food and Drug Administration. Our experience with Class 2 medical devices is wide ranging, from simple devices like surgical gloves (which require a 510k) to complex software-related systems. We can help you obtain FDA approval for your medical device and do so quickly so you can start selling sooner.
In addition to our FDA 510(k) services, Emergo Group offers a wide range of medical device consulting services. We can help you implement FDA Good Manufacturing Practices or ISO 13485:2003, obtain the CE Mark, find medical distributors or assist with many other quality and regulatory issues related to the US, Canada, China, Japan, Europe or Australia.
