Daily Archives: January 9, 2022

What is UDI

What is UDI Unique Device Identification or UDI is a system that provides harmonized positive, globally and single identification of medical devices through usage and distribution. The system has two parts, which are UDI-PI and UDI-DI. The UDI-DI is the device identifier that has the power to identify a particular device within your portfolio, which…

ISO 14971 Risk management

ISO 14971 RISK MANAGEMENT FOR MEDICAL DEVICES Let’s review the background of ISO 14971. As a medical device manufacturer, the first thing you need to do is to make sure that your devices do what they are supposed to do. Then, you need to make sure that they meet the set regulations and standards for…