Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 1)
by January 9, 2023 | Blog|
We couldn’t be more excited about 2023, but before we move forward, let’s take a look back at all our accomplishments.
So, let’s wrap up the incredible, unpredictable and unprecedented year 2022 with the eyes of a winner!
- Introducing Genesis 6.1.7: Innovit launched our multi-tenant version of the Genesis MDM platform, code-named “cloud” in March 2021 with a pilot group of early adopter customers. In October 2021, it was made available to all Australian and New Zealand customers, and most of our ANZ customers have already moved to this new, multi-tenanted SaaS platform, which is built on the latest cloud technology. Genesis MDM offers a modern user experience, master data validation, prepackaged workflow automation, and guided navigation.
- UDI Connector for EUDAMED: Innovit’s medical device customers who are impacted by Europe’s MDR can use our “UDI Connector for EUDAMED” (aka EUDAMED Connector) as a solution that enables medical device manufacturers to submit structured and unstructured data to the EU Commission’s EUDAMED system. Manufacturers automatically receive a prepackaged list of product attributes, code lists, and validation rules for submission to EUDAMED. In addition, manufacturers can import, link, and submit regulatory documents associated with a device via the Basic UDI-DI. Our EUDAMED solution is validated to GAMP5 standards, and compliant with EU’s Annex 11 guidelines.
- UDI Connector for GUDID: Innovit’s solution for GUDID compliance is validated to GAMP5 standards and compliant with the FDA’s 21 CFR Part 11 guidelines that provide device ‘labelers’ and manufacturers with a prepackaged list of attributes, code lists, and validation rules for submission to the FDA’s GUDID system. Innovit’s UDI Connector also automates the submission of UDI data using HL7 SPL standards – the specific data format, and messaging protocol required by the FDA.
- atrify Partnership: Innovit has strengthened its strategic partnership with atrify to provide a full suite of PIM and GDSN solutions for managing product information and for synchronizing product data, including regulatory data submissions for Unique Device Identification (UDI), content marketing, and B2B eCommerce with GPOs and hospitals. Innovit and atrify customers can now leverage a comprehensive PIM offering integrated with atrify’s world-class GDSN data pool, to manage both regulatory and commercial product data. This includes UDI submissions to the European Database on Medical Devices (EUDAMED), the FDA’s Global Unique Device Identification Database (GUDID), and the Chinese NMPA’s Medical Device Registration Database (UDID), as well as content transfers to GS1’s Global Data Synchronization Network (GDSN). Learn more
- UDI Reference Centers: The compliance landscape is diverse, growing, and constantly changing. Over the past year, Innovit has worked hard to collect data, develop content, and set up our website infrastructure to share the latest information on dedicated knowledge-based reference centers for EUDAMED, GUDID, and a global UDI reference center. Check it out!
- The EUDAMED Leadership Council (ELC): We met again many times this year as a representative advisory panel to provide expert guidance, advice, and/or recommendations on the European Commission’s EUDAMED data requirements under the MDR and IVDR. Participants include many leading medical device manufacturers. For 2023, we plan to transform the group into a global regulatory committee dedicated to sharing expertise and practical experience in “global UDI” compliance, leveraging the strengths of individual participants toward this common goal.