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The Computer System Validation pilot program is exploring ways for device manufacturers to save time in implementing new information technology tools that support quality systems and other operational functions. One strategy under review: letting companies rely on software manufacturers’ own validation for low-risk functions. Also: A quality assurance manager at device-maker Zoll Medical weighs in on his company's participation in the pilot.
The xMap Multiflex Zika RNA Assay is a molecular diagnostic that is designed to detect the Zika virus in human serum, urine or plasma.
Gamma camera mechanical failures and surveillance challenges with telemetry-monitored patients monitored are two risks that have been elevated to the nonprofit ECRI Institute's Top 10 technology hazards for the first time in its 2016 listing, while inadequate cleaning of flexible endoscopes and missed alarms on monitoring equipment continue to be highlighted in the annual ranking.
Altona Diagnostics GmbH has received emergency-use authorization for its Middle East Respiratory Syndrome Coronavirus diagnostic.
- Medical Devices
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- Siemens AG
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Martin Weitzner, Director, Corporate Information
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