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Video: Planning for Med Device Label Changes for EU UDI


Video: Planning for Med Device Label Changes for EU UDI

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For a quick dive into the key MDR/IVDR changes and anticipated impacts to process and stakeholders, listen to this brief discussion for the Reed Tech Insights Series.

The 7 core elements of ISO 14971

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Risk Management for the Medical Device Industry: What is ISO 14971? ISO 14971 is an International standard that describes a systematic approach for medical device risk management. ISO 14971 has been recognized as a consensus standard by most regulatory agencies around the world including the U.S. FDA, Health Canada and the European Union Competent Authority. […]

The Continuing Evolution of UDI: Highlights from the 2018 UDI Conference (Part 2 of 2)

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Please note, this is Part Two of a two-part blog on the 2018 UDI Conference. You can read Part One here. FDA Makes GUDID Changes to Improve Data Quality Throughout the UDI Conference, FDA representatives continued to drive home the message of their 2018 data quality campaign during multiple sessions. In particular, Indira Konduri of […]

UDI Flows Downstream: Highlights from the 2018 UDI Conference (Part 1 of 2)

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 At the end of April, medical device regulatory professionals, FDA representatives, technology providers and other industry members met together in Baltimore to discuss all things related to Unique Device Identification at the annual UDI Conference. If there was one overarching theme to the conference presentations and conversations overheard in the exhibit hall, at the lunch […]

FDA is Sharpening its Focus on UDI Data Quality

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In recent months, the Food and Drug Administration has continued to build on its message of the importance of data quality in its Unique Device Identification database, the GUDID. In a recent presentation to the Dental Trade Alliance, FDA GUDID Program Manager Indira Konduri reminded medical device industry members to avoid common data quality errors […]


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