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Key Takeaways from the Europe Commission’s New EUDAMED Data Exchange Guidelines

by Innovit Corporate Affairs | May 28, 2019 | Blog, Eudamed

As it prepares to meet new regulatory requirements in Europe, the medical device community is following developments regarding the European Database for Medical Devices (Eudamed).  Most recently, the European Commission (EC) released three documents for Medical Device...

The Latest UDI News: Convenience Kits Q&A from the FDA

by Innovit Corporate Affairs | May 21, 2019 | Blog, UDI

Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labeling of...
No-Deal Brexit – Implications to Medical Device Regulations (MDR)

No-Deal Brexit – Implications to Medical Device Regulations (MDR)

by Innovit Corporate Affairs | Feb 13, 2019 | Blog, MDR

A no-deal Brexit (a disaster to some or the chance trade on our own terms to others) means the UK would leave the European Union (EU) immediately on 29 March 2019, and there would be no agreements in place about what their relationship would be like in future.  It...
Latest developments on GDSN and Master Data Excellence.  Innovit heads to Brussels for the GS1 Global Forum.

Latest developments on GDSN and Master Data Excellence. Innovit heads to Brussels for the GS1 Global Forum.

by Innovit Corporate Affairs | Feb 12, 2019 | Blog, GDSN

The GS1 Global Forum, scheduled to kick-off next week on February 18, 2019 in Brussels – is GS1’s largest global annual event aimed at aligning the organization’s strategy while strengthening the GS1 staff around the world. The week offers great opportunities to...
Leveraging Your Wealth of Healthcare Data for Better Patient Care

Leveraging Your Wealth of Healthcare Data for Better Patient Care

by Innovit Corporate Affairs | Feb 7, 2019 | Blog, MDR

Innovit at GS1 UK Healthcare Conference, London   Managing the wealth of available healthcare data allows health systems to create holistic views of patients, personalize treatments, improve communication and enhance health outcomes. Additionally, data continues...
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Recent Posts

  • Regulatory Update: Australia’s UDI Regulation Now in Effect
  • EUDAMED Go-Live Announcement: Streamlined UDI Data Submission using Innovit EUDAMED Connector
  • Updated Timeline: Mandatory Use by Q4 2025 – Current planning for gradual roll out and modules’ functionality view
  • MDR Third Amendment is official: EUDAMED Mandatory Use by January 2026

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