EU-MDR Date of Application – Postponed…

The European Parliament has formally voted and adopted the amendment of its Medical Device Regulation (MDR) date of application. The Parliament has tabled and supported the 4 technical amendments proposed last week by the European Council, without bringing additional...

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GUDID and UDI – Are You Prepared?

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every medical device with an identifier.  Unique Device Identification (UDI) is a system to mark and identify medical devices (via...

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EUDAMED: Regulation News & Updates

The European Commission recently announced last November that the new EUDAMED will not launch until May 2022, even as the MDR takes effect in May 2020.  While the delay in EUDAMED certainly helps give us more time before we must submit information to the database...

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Healthcare Insights – 2019 Recap

Happy New Year! As the dust settles from the holiday madness and end-of-year celebrations, we thought we’d take a quick look back and reflect upon our 2019 journey. We’re so fortunate to work with an amazing roster of customers and partners whose relationships are...

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