Innovit Client Completes M2M Tests with AusUDID and EUDAMED
Innovit is thrilled to announce that one of our customers, a global medical device company and leader in new product development and medical education in orthopedics, was the first to successfully complete M2M testing with AusUDID and one of the first to also successfully complete M2M EUDAMED testing.
The 12 Most Important Steps to Global UDI Compliance
The Staggering Number of Global UDI Requirements Demand Immediate Action in 2023Â The importance of accurately managing product data is evident in healthcare. After all, most of these products have a direct impact on people's health: Things like heart valves,...
Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 2)
Welcome back! If you missed our 2022 re-cap in part one of this blog series, you can find it here. If you’re already caught up…
Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 1)
Medical Device Manufacturers in the US have many questions as the Dec 8, 2022 GUDID compliance deadline approaches. This blog will answer some of the most common questions, and ensure everyone has the answers they need to begin their journey toward the FDA’s GUDID Class I Compliance.Â
FDA Class I GUDID Compliance Regulation FAQ’s
Medical Device Manufacturers in the US have many questions as the Dec 8, 2022 GUDID compliance deadline approaches. This blog will answer some of the most common questions, and ensure everyone has the answers they need to begin their journey toward the FDA’s GUDID Class I Compliance.Â
9-Steps to GUDID Class I Medical Device Compliance
Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements and guidelines for active medical devices.
Brazil’s UDI Update: ANVISA plans major medical device registration updates
Brazil’s medical device market regulator, ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001.
Australian Unique Device Identification (UDI) Framework: Medical Device UDI Implementation, Essential Principles Guidance
Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements and guidelines for active medical devices.
Unlocking & Empowering your Understanding of the Global Data Synchronization Network (GDSN) – Part 2
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
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 implementations to more dispersed methods that allow multiple connections to utilize the same information, such as the Global Data Synchronization Network (GDSN).