GoingToMeet

With the upcoming mandate by the FDA of the use of their Electronic Medical Device Reporting System (eMDR) all medical device manufacturers will be required to create and submit MDRs via the FDA's Electronic Submission Gateway or FDA ESG. The long and tedious task of making this connection to the gateway has many steps and takes a considerable amount of time between steps to complete the process. The connection process begins with a series of paperwork/letters which must be provided, through the set up of the Test System Gateway, to the sending of a large file (7G) across the gateway to the final step of achieving access to the Production Gateway. This one hour session will provide an overview of the specific steps require to complete a successful connection to the FDA ESG. Whether you are the IT professional or the QA, RA or Engineer who will be responsible for this action, this webinar will be instrumental in providing you with the insight to complete the task.