Complimentary Training –
eCopy for Medical Devices
In 2013 the FDA began requiring an electronic version of all medical device submissions known as “eCopy’.
On December 3, 2015, the FDA’s, “Center for Devices and Radiological Health” (CDRH), issued a revised version of the guidance document, “eCopy Program for Medical Device Submissions.”
Aquila’s training shall investigate the purpose of this FDA guidance, explain the electronic (eCopy) program for medical device submissions and shall provide information for processing eCopies.