Three Ways that Innovit is Leading the Charge in Healthcare Compliance

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, these repositories capture important regulatory and clinical information about medical devices.  Of course, the primary goal of these various regulations […]

Country-Specific UDI Compliance – Staying Up to Date on Changing Deadlines

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 deadlines for implementation are looming. Every “labeler” of medical devices in America is required to maintain UDI data […]

EUDAMED State of Play – New Playground Available for EUDAMED Device Registration and NBs & Certificates modules

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- based user access, and an automated M2M (machine‑to‑machine) Data Exchange for Actor Registration, Notified Bodies (NBs) […]

Innovit Q&A: M2M Testing – What it means and why it’s important.

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 Device Directives) first established in 1992.  Key elements of the new MDR include the expansion […]

NEWS: EUDAMED State of Play: EU Commission delays EUDAMED Device Registration Go-live

Part IV – Mayo Clinic: Improving Strategic Supply with Trusted Data

Part III – Mayo Clinic: Improving Strategic Supply with Trusted Data

Part II – Mayo Clinic: Improving Strategic Supply with Trusted Data

Part I – Mayo Clinic: Improving Strategic Supply with Trusted Data

EUDAMED: Playground Testing Update

EUDAMED go-live date is still scheduled for May 2022.  In order to ensure a smooth and effective implementation, the EU COM is providing a “EUDAMED playground” available for both manual web‑based user access and an automated M2M (machine‑to‑machine) Data Exchange for Actor Registration, Notified Bodies and Device Registration modules.  Three solution providers – including Innovit […]

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