Michelle Laurion Archives

Unlocking & Empowering your Understanding of the Global Data Synchronization Network (GDSN) – Part 2

by Michelle Laurion | Aug 17, 2022 | Blog, Michelle Laurion

Getting Started With the GDSN In our previous blog, we discussed what the GDSN is. In today’s blog, we’ll go over what companies can expect and should prepare for when starting their GDSN journey. As with any journey, how you start can make a big difference,...

Unlocking & Empowering your Understanding of the Global Data Synchronization Network (GDSN) – Part 1

by Michelle Laurion | Aug 9, 2022 | Blog, Michelle Laurion

Announcing Innovit’s GDSN Blog Series! Sharing information about products and devices is a cornerstone of modern supply chains, regulatory compliance departments and ecommerce platforms. There are several options to facilitate this sharing, from point-to-point...

FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline

by Michelle Laurion | Jul 29, 2022 | Blog, Michelle Laurion

On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “Unique Device Identification: Policy Regarding...

We’re Excited To Be Back In Person! Announcing Innovit’s 2022 Event Calendar

by Michelle Laurion | Mar 3, 2022 | Blog, Michelle Laurion

As we look ahead with optimism to traveling again in the coming year, with some expected bumps along the way, we’re thrilled to share Innovit’s return to in-person events in 2022! No doubt we’ve all gained some new appreciation for ‘real’ in-person events – so we...

FAQ: Global Unique Device Identification Database (GUDID)

by Michelle Laurion | Feb 8, 2022 | Blog, Michelle Laurion

What is GUDID? GUDID is an acronym for the Global Unique Device Identification Database — a central repository of detailed medical device information created by the US FDA. It is often pronounced “Good ID”. The GUDID system was implemented as a component of the...

Introducing Innovit’s EUDAMED Reference Center

by Michelle Laurion | Jan 11, 2022 | Blog, Michelle Laurion, News

As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices. Even the most experienced companies uncover critical gaps in...

Unlocking & Empowering your Understanding of the Global Data Synchronization Network (GDSN) – Part 2

Unlocking & Empowering your Understanding of the Global Data Synchronization Network (GDSN) – Part 1

FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline

We’re Excited To Be Back In Person! Announcing Innovit’s 2022 Event Calendar

FAQ: Global Unique Device Identification Database (GUDID)

Introducing Innovit’s EUDAMED Reference Center

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