Sep 26, 2017 | Medical Devices, White Paper
The White Paper provides real-world and practical information directed to the manufacturer of Class II and Class III devices in navigating the Premarket Notification 510(k) clearance with insight into the various documentation required by FDA for submitting a 501(k)…
Aug 1, 2017 | Issue of the Month, Medical Devices
By EAS Independent Consultant, Joe Ouellette If you are a manufacturer whose medical device is either a Class I, or a 510(k) exempt device Class II device, consider yourself and your company lucky that you do not have to try to “thread the needle” of the litigious and...
