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UDI Compliance

The FDA’s UDI Compliance Mandate in Plain English – How We Can Help!

We formed UDI Compliance Solutions, LLC to help make the path to compliance easier and faster!

By |July 30th, 2015|UDI Compliance, UDI Solutions|

The FDA’s UDI Compliance Mandate in Plain English – The Label

The FDA UDI mandate calls for the placement of Device Identifiers (DI) and Production Identifiers (PI) on a UDI label.

By |April 8th, 2015|UDI Compliance, UDI Solutions|

The FDA’s UDI Compliance Mandate in Plain English – How Long?

The FDA deadlines serve to give medical device companies a target date to shoot for, however

By |March 30th, 2015|UDI Compliance, UDI Solutions|

The FDA’s UDI Compliance Mandate in Plain English – Introduction

The premise on which the concept of a unique identifier is founded is far too important and far more complex than just having to label a medical device a certain way.

By |March 23rd, 2015|UDI Compliance, UDI Solutions|

What Is UDI Compliance?

The Unique Device Identification (UDI) system mandated by the FDA is designed to protect patient safety and require the proper identification of medical devices.

By |October 17th, 2014|UDI Compliance|

UDI Compliance Solutions Answers

As the effective dates for UDI Compliance and enforcement edge closer there is suddenly a huge waive of information that is becoming available on a daily basis with regard to the suggested best practices and necessary filing requirements of the new FDA regulations and GUDID filing system. Unfortunately, as is often the case with documentation […]

By |March 25th, 2014|Charts, UDI Compliance, UDI Solutions|