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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.
June 7th, 2022 — Innovit, the Product Information Management (PIM) specialists who enable Healthcare Providers and Medical Products Suppliers to deliver trusted product data for supply chain management and clinical performance optimization, today announced their GDSN.cloud solution enabling healthcare manufacturers to easily share accurate & validated product data to the GDSN.
San Francisco, CA (June 3, 2022) Innovit, the Product Information Management (PIM) specialists in enabling healthcare providers to deliver trusted data best practices in supply chain and clinical performance and atrify, a leading provider of...
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...
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...
First things first. What exactly is a Data Flow Model? A data flow model is diagrammatic representation of the flow and exchange of data within a system. Data flow models are used to graphically represent the flow of data in an information system...
After four years of transition followed by a global pandemic in 2020, we reached a regulatory milestone on May 26, 2021 for Medical Device manufacturers in the European Union – with Medical Device Regulation 2017/745 finally taking effect. Yesterday, being the date of application of EU Medical Device Regulation (MDR) marks an important event for the medical devices market.
Today, medical device manufacturers are facing a wide array of data compliance demands from healthcare providers, and national regulators including the European Commission, FDA and China’s NMPA. With the introduction of GUDID and now EUDAMED,...
UDI Timeline: A progression of UDI compliance regulations and deadlines. One thing in healthcare is certain: patient safety and quality of care will continue to drive change in the healthcare market. UDI regulations support this objective and...
What’s New? EUDAMED go-live date is still scheduled for May 2022. But you may recall that in order to ensure a smooth and effective implementation, the EU Commission provides a “EUDAMED playground.” It’s currently available for both manual web-...
Medical Device Regulation (MDR) are a set of recent European regulations aimed to enhance patient safety and modernize public health. Published in May 2017 by the European Commission (EU COM), they are an overhaul and expansion of the MDD (Medical...