UDI Archives | Innovatum

Life Sciences Labeling Outlook

Leave a Comment / Compliance, ROBAR Labeling, UDI / KME Digital

Life science labeling organizations face substantial challenges in navigating regulatory compliance, managing data integration, ensuring labeling accuracy, and scaling for growth in an increasingly complex global environment. To meet these demands, comprehensive enterprise labeling systems can provide a robust solution, helping organizations streamline workflows and maintain compliance efficiently. Regulatory Compliance Life science labeling is highly […]

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What I Learned While Presenting in Front of the FDA About UDI Management

Leave a Comment / UDI / Mark Sikorski

I was invited to speak at a UDI-centric conference a few weeks ago in which FDA made presentations and attended mine. Jay Crowley, Indira Konduri- (US FDA’s GUDID Program Manager) and representatives from GS1, ICCBBA and other organizations also presented. I was presenting on behalf of the AIM North America Healthcare Committee on the topic

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Taiwan’s Version of Unique Device Identification

Leave a Comment / UDI / Mark Sikorski

Medical Device Manufacturers the world over are striving to stay abreast of developments as regulatory bodies other than the US FDA release details concerning their approach to Unique Device Identification for medical devices. Taiwan is progressing in the area of UDI, having produced a guidance document late last year. Within this guidance information it is

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Real Benefits of UDI in the Operating Room and Beyond

Leave a Comment / UDI / Mark Sikorski

Let’s face it, there are still those amongst us who grumble at the mention of having to comply with the UDI regulations. To them, it’s simply a matter of having to comply to stay in business. There are those of us however, who are advocates of the regulation and appreciate the benefits of UDI. We

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UDI Implementations In Full Swing With Innovatum

Leave a Comment / UDI / Mark Sikorski

So far this summer is off to a sizzling start with Innovatum managing seven global labeling UDI implementation projects concurrently. Four of these projects had their go live take place in the month of June 2015 alone! In conjunction with successfully submitting significant amounts of product UDI attribute information to the FDA Production Global UDI

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2015 UDI Conference Highlights

Leave a Comment / UDI / Mark Sikorski

Although the 2015 UDI Conference had record participation, many Medical Device Manufacturers were not able to attend, consequently this summarization of highlights from the sessions should be of value. FDA kicked the first session off with an overview of UDI, a review of compliance dates, a listing of benefits derived from UDI and an update

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What Do Software Validation Services Entail?

Leave a Comment / Compliance, UDI / Mark Sikorski

During the course of software engineering, testing and software project management, validation refers to the process of verifying that a software solution meets required specifications. This is a formalized process and is required within the life sciences. Software validation will ensure that your software solutions comply with requirements. Failing to do so can result in

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Medical Device Labeling Guidelines

Leave a Comment / UDI / Mark Sikorski

Medical device labeling guidelines have been updated by the U.S. Food and Drug Administration (FDA) with the aim of clarifying the ways in which medical devices may be labeled in order to prevent confusion for caregivers, patients and medical staff. The FDA’s final rule has established a system for the unique identification of medical devices

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Understanding Unique Device Identification

Leave a Comment / UDI / Mark Sikorski

Unique Device Identification (UDI) refers to a system that is designed to mark the labels of medical devices used within the healthcare system. The U.S. FDA released a final ruling on the system in 2014. The system is intended to be fully implemented over the next several years.

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Understanding the Difference between Class I, Class II and Class III Medical Devices

Leave a Comment / UDI / Mark Sikorski

The U.S. Federal Drug Administration (FDA) classifies medical devices. There are three main classifications Class I, Class II, and Class III. The assignment of a classification for a device depends upon the level of risk that is associated with the device.

Understanding the Difference between Class I, Class II and Class III Medical Devices Read More »

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UDI

Life Sciences Labeling Outlook

What I Learned While Presenting in Front of the FDA About UDI Management

Taiwan’s Version of Unique Device Identification

Real Benefits of UDI in the Operating Room and Beyond

UDI Implementations In Full Swing With Innovatum

2015 UDI Conference Highlights

What Do Software Validation Services Entail?

Medical Device Labeling Guidelines

Understanding Unique Device Identification

Understanding the Difference between Class I, Class II and Class III Medical Devices