Search Results for interoperability

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ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable By Zachary Brennan - Published 11 January 2018

The International Coalition of Medicines Regulatory Authorities (ICMRA) is focusing on aligning existing and planned track and trace systems worldwide, with an eye toward interoperability as many of the existing and planned systems were designed with a national or regional focus.

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Quality, Regulatory intelligence

Tags: ICMRA, track and trace, interoperability

Interoperable Medical Devices: FDA Offers Design, Labeling Considerations By Zachary Brennan - Published 25 January 2016

With an eye on helping medical device manufacturers ensure their products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on how to design such interoperable devices, as well as recommendations for labeling.

Categories: News, US, CDRH, Due Diligence, Labeling, Medical Devices, Regulatory strategy

Tags: interoperable devices, medical devices online, device interoperability, FDA draft guidance