The video provided below shows you exactly what you will receive when you purchase our UDI Requirements Procedure (SYS-039).
This procedure is updated for ISO 13485:2016, and the following is a list of documents included:
- SYS-039 A, UDI Requirements Procedure
- FDA GUDID Data Elements Spreadsheet
We are also including a training webinar explaining the FDA’s UDI System, the native presentation slide deck, and we provide an exam (i.e., 10-question quiz) to verify training effectiveness. If you submit the completed exam to us by email in the native MS Word format, we will correct the exam and email you a training certificate with your corrected exam. The FDA website also provides information about the UDI system.
SYS-039, UDI Requirements Procedure Bundle; This training includes our procedure for UDI Requirements and the FDA template for the GUDID data elements. You will also receive a link to download our slide deck and webinar recording on UDI labeling. We also provide a 10 question quiz on the FDA’s UDI requirements and a training certificate when you complete the quiz and submit it to Medical Device Academy for grading.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.