FDA UDI Implementation in 12 Steps
Sam Lazzara Resume LinkedIn Profile Documents Services Schedule Call +1 510 397 9739 sam@lazzara.net Here is a high level task list intended for medical device labelers who want to implement FDA requirements for Unique Device Identification. Check out this blog page for general information related to UDI. 1. Determine FDA 21 CFR requirements applicable to your devices. 2. Perform gap analysis between FDA requirements and current quality system. 3. Create Quality Plan for UDI implementation. 4. Select FDA-accredited issuing agency. Become member and obtain company prefix. 5. Select and procure label printing system (printer and software). Same goes for device marking system if required. 6. Design and procure package label stock(s) with primary printing. 7. Choose barcode style to be employed on package labels and/or device itself. 8. Develop secondary/production label printing “artwork” using software.Same goes fo