Let us help you on the path to UDI Compliance for FDA with Innovit’s GUDID Reference Center

Are you preparing for the FDA’s enforcement of UDI labeling and GUDID (Global Unique Device Identification Database) data submission requirements for Class I and unclassified devices, coming up in September 2022?  Your company should start to aggregate, validate and submit your regulatory data for Class I medical devices — today! Innovit is here to help […]

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

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 can’t wait to see you!   We kick-off this […]

FAQ: Global Unique Device Identification Database (GUDID)

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 FDA’s Unique Device Identifier (UDI) regulations, and serves as a digital […]

Start your Class I FDA GUDID data submission journey with these initial steps!

It’s hard to believe we’re more than halfway through January! You should be thinking and planning for the FDA’s GUDID compliance deadline for Class I medical devices.  September 24, 2022 is just around the corner!     Time certainly flies – and even with the postponement of the FDA’s enforcement data for UDI labeling and GUDID data […]

Introducing Innovit’s EUDAMED Reference Center

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 their own internal systems and master data.   Under current timelines, a […]

Innovit’s 2021 Recap and a Look Ahead!

2022 is almost here and the holiday season is in full flight!   As another turbulent year comes to an end, the team at Innovit took a moment to reflect on the past year while also looking ahead with zeal and optimism.  Though agility and adaptability are nothing new to us seasoned veterans in the healthcare industry, the past 20 months has seen unprecedented and tectonic shifts in the global healthcare value chain […]

Your New Year’s Resolution!
Five easy steps for Risk Class I data submissions to FDA GUDID!

With the new year almost upon us, the FDA’s GUDID compliance deadline for Class I medical devices must now be met with urgency.  September 24, 2022 is just around the corner!    In an effort to help the industry remain focused on COVID-19 response efforts, while still providing high-quality UDI data submissions, in July of 2020 the FDA announced a two-year postponement of its enforcement date for UDI labeling and GUDID data submission requirements for Class I […]

Gain market insight & a deeper understanding of EUDAMED requirements. Join the EUDAMED Leadership Council!

Innovit is excited to announce the formation of a EUDAMED Leadership Council Group on LinkedIn which includes participants from a number of leading medical device manufacturers including Arthrex, B. Braun, Bio-Rad, Medtronic, 3M, Molnlycke, Ascensia Diabetes.  The EUDAMED Leadership Council is a representative advisory body that provides informed guidance, advice, and/or recommendations on the European Commission’s EUDAMED data requirements under MDR and IVDR.    The formation of this Leadership […]

Introducing MDM.Cloud

We’re excited to introduce you to Innovit’s next-generation solution, MDM.cloud for the Australian market! Current iICE Validator customers can take advantage of our MDM.cloud system upgrade NOW! MDM.cloud for NPC was initially created for the National Product Catalogue publications use case, and is intended to replace the iICE Validator system which will become unsupported by the end of November 2021. As a current iICE Validator […]

Device Registration ‘is live’ for voluntary UDI data submission on EUDAMED

Last week, the European Commission announced the successful launch of its EUDAMED “Device Registration” and “NBs & Certificate” modules (Production release “v2.0 – September version” was deployed).  The EUDAMED UDI/Device Registration and NBs & Certificates modules have been successfully deployed into the Production environment and are available for use as of 4th October 2021.   You can find links to the EUDAMED restricted website and the public website below:  EUDAMED restricted  […]

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