Kidd & Co-backed NexPhase Medical Devices has acquired Proven Process Medical Devices. The deal expands the platform’s expertise in R&D, engineering, design and manufacturing of FDA Class II and III ...
In 2000, the FDA began to view and regulate all companies reprocessing single-use medical devices in the same way it viewed and regulated original equipment manufacturers (OEMs). Before returning ...
The Institute of Medicine (IOM) has released a report highly critical of the FDA's 510(k) medical device clearance process and called on the FDA to develop "a new framework that used both premarket ...
BOSTON--(BUSINESS WIRE)--908 Devices Inc., (Nasdaq: MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biochemical analysis, announced that National Resilience, Inc.
Process maintenance teams have long been challenged with gaining access and connectivity to service their field-level devices. Traditionally, plant personnel needed to walk out to the processing area ...
The US Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new ...
New process device profiles have been added by ODVA to the EtherNet/IP specification to provide end users with another tool to help optimize plant operations. According to ODVA, the new process device ...
Industry 4.0 initially focused on discrete manufacturing, and now there is a growing focus on applying Industry 4.0 concepts to process automation. The same concepts are being applied to process ...
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